summer trainning sanofi final

7/31/2019 Summer Trainning Sanofi Final

1/47

PROJECT REPORT

ONPERCEPTIONS OF DOCTORS ABOUT

SOLIAN (AMISULPRIDE) FOR THE

TRAETMENT OF SCHIZOPHRENIA

MASTER OF BUSINESS ADMINISTRATION

(PHARMACEUTICAL MANAGEMENT)

DEPARTMENT OF MANAGEMENT

FMIT

JAMIA HAMDARD

NEW DELHI-110062

Submitted to: Submitted by:ADNAN EJAZ

MBA (PM)
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


2/47

CHAPTER CONTENTS PAGE

NO:

CERTIFICATE

ACKNOWLEDMENT

STUDENTS DECLARATION

EXECUTIVE SUMMARY

CHAPTER -

1 INTRODUCTION

CHAPTER-2 LITERATURE REVIEW

CHAPTER-3

RESEARCH METHODOLOGYv SCOPEv OBJECTIVEv RESEARCH DESIGNv LIMITATIONS

CHAPTER-4 DATA ANALYSIS FINDINGS

CHAPTER-5 CONCLUSION

CHAPTER-6 BIBLIOGRAPHY


3/47

CERTIFICATE FROM FACULTY


4/47

ACKNOWLEDMENT

First and the foremost I thank ALMIGHTY for his divine blessings and grace for the successful

completion of the project smoothly.

I express my sincere gratitude to Mr. SHIBU JOHN, Faculty of management and information

technology, Jamia Hamdard. New Delhi.

I express my sincere and profound thanks to SANOFI, MR. PUNEET CHAHBRA & Mr.

DHARMVEER(Head- Area Business Manager, Sanofi India) for allowing me to complete my

project in this renowned Pharmaceutical Company.

I would like to express my gratitude to Dr. N. RAVICHANDRAN , Head of the Department,

Department of Management Jamia Hamdard, New Delhi.

Words fail to express my love and indebtedness to my beloved parents for the successful

completion of this work.

Last but not the least, I express my thanks to the Doctor s for their cordial behavior and

support.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


5/47

DECLARATION

I hereby declare that the project work entitled PERCEPTIONS OF DOCTORS ABOUT

SOLIAN (AMISULPRIDE) FOR THE TRAETMENT OF SCHIZOPHRENIA is based

on the original work done by me for the Summer Project of MBA (PM) Program, requirementfrom JAMIA HAMDARD, New Delhi. This project work is a bonafide record of the carried out

work with Sanofi india, delhi branch under the supervision of Mr. Puneet Chahbra & Mr.

Dharmveer and under the guidance of Mr. Rahul Jain, Faculty of management and information

technology, Jamia Hamdard. New Delhi.

No part of this project has been included in any other project submitted for the award of any

degree or diploma.

ADNAN EJAZ

MBA(P.M)


6/47

EXECUTIVE SUMMARY

.

The present report is on PERCEPTIONS OF DOCTORS ABOUT SOLIAN

(AMISULPRIDE) FOR THE TRAETMENT OF SCHIZOPHRENIA.

To study the current status future acceptance of solian brand . A fair side is brought up about

which constitute the comparative study of Solian (amisulpride) drugs with the different

chemical drugs.

The methodology has made the report more precise as it would give a fair idea as to what all

means were used to gather information. The research tool which used to prepare this report was

in-depth interviews from the various Psychiatrist Doctor s.

A detailed study of the report can be seen in the one to one discussion with the Psychiatrist

Doctor s in the research methodology section which would constitute a definite aspect in

building up title project work. The findings from this report gives us the fair idea about the

future market scenario of the same drugs and various reasons about the same.


7/47

CHAPTER-1


8/47

1.IntroductionSolian tablets and solution contain the active ingredient amisulpride, which is a type ofmedicine known as an atypical antipsychotic. ( Amisulpride is also available without a brandname, ie as the genericmedicine.) It is used to treat schizophrenia.

Amisulpride works in the brain, where it affects a neurotransmitter called dopamineNeurotransmitters are chemicals that are stored in nerve cells and are involved in transmittingmessages between the nerve cells.

Dopamine is a neurotransmitter known to be involved in regulating mood and behaviour,amongst other things. Schizophrenia is associated with an overactivity of dopamine in the brain,and this may be associated with the delusions and hallucinations that are a feature of thisdisease.

Amisulpride works by blocking the receptors in the brain that dopamine acts on. This preventsthe excessive activity of dopamine and helps to control psychotic illness.

People with schizophrenia may experience 'positive symptoms' (such as hallucinationsdisturbances of thought, and hostility) and/or 'negative symptoms' (such as lack of emotion andsocial isolation).

Amisulpride has been shown to be effective for relieving both positive and negative symptomsof schizophrenia, whereas the conventional antipsychotics are usually less effective against thenegative symptoms.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.netdoctor.co.uk/medicines/brand_generic.htmhttp://www.netdoctor.co.uk/medicines/brand_generic.htmhttp://www.netdoctor.co.uk/medicines/brand_generic.htmhttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


9/47

1.1

About company:

Sanofi-aventis is one of the leading pharmaceutical companies of the world. We are present in

over 100 countries and have about 100,000 employees across the world, all united in thepurpose of health.

Sanofi-aventis has number of powerful assets to address the new context in the globalpharmaceutical market: worldwide presence, an extensive portfolio of prescription medicines,market leadership in vaccines, major biological products, generics medicines, consumerhealthcare, animal healthcare, and has a strong and long-established presence in both traditionaland emerging markets.

Vaccines: Sanofi Pasteur, the vaccines division of sanofi-aventis, offers the broadest range ofvaccines in the world, providing protection against over 20 infectious diseases. The divisionprovided more than 1.6 billion doses of vaccine in 2009, supporting vaccination of more than500 million people worldwide. Sanofi Pasteur is currently the world leader in vaccineproduction and sales.

Sanofi-aventis in India operates through four entities - Aventis Pharma Limited, Sanofi-Synthelabo (India) Limited, Sanofi Pasteur India Private Limited and Shantha Biotechnics.

Sanofi-aventis and its 100% subsidiary Hoechst GmbH are the major shareholders of AventisPharma Limited and together hold 60.4% of its paid-up share capital. Sanofi-Synthelabo (India)Limited and Sanofi Pasteur are 100% subsidiaries of sanofi-aventis Group. Aventis PharmaLimited is listed on the Bombay Stock Exchange and the National Stock Exchange.

Aventis Pharma Limited was incorporated in May 1956 under the name Hoechst Fedco PharmaPrivate Limited. Over the years, its name was changed to Hoechst Pharmaceuticals PrivateLimited, Hoechst India Limited and Hoechst Marion Roussel Limited. The shares of AventisPharma Limited are quoted on the Bombay Stock Exchange and the National Stock Exchange.

Aventis Pharma Limited [India] has around 2,300 employees. It has state-of-the-artmanufacturing facilities in Ankleshwar and Goa, where active pharmaceutical ingredients andformulations are manufactured.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


10/47

Schizophrenia is a mental disorder characterized by a breakdown of thought processes and bypoor emotional responsiveness. It most commonly manifests itself as auditoryhallucinations,paranoid or bizarre delusions, or disorganized speech and thinking, and it isaccompanied by significant social or occupational dysfunction. The onset of symptoms

typically occurs in young adulthood, with a global lifetime prevalence of about 0.30.7%. Diagnosis is based on observed behavior and the patient's reported experiences.

Genetics, early environment, neurobiology, and psychological and social processes appear to beimportant contributory factors; some recreational and prescription drugs appear to cause orworsen symptoms. Current research is focused on the role of neurobiology, although no singleisolated organic cause has been found. The many possible combinations of symptoms havetriggered debate about whether the diagnosis represents a single disorder or a number ofdiscrete syndromes.

Schizophrenia does not imply a "split personality", or "multiple personality disorder" (which is

known these days as dissociative identity disorder) a condition with which it is often confusedin public perception. Rather, the term means a "splitting of mental functions", because of thesymptomatic presentation of the illness.

The mainstay of treatment is antipsychotic medication, which primarilysuppresses dopamine (and sometimes serotonin)receptor activity. Psychotherapy andvocational and social rehabilitation are also important in treatment. In more serious caseswhere there is risk to self and others involuntary hospitalization may be necessary, althoughhospital stays are now shorter and less frequent than they once were.

The disorder is thought mainly to affect cognition, but it also usually contributes to chronicproblems with behaviour and emotion. People with schizophrenia are likely to have additional(comorbid) conditions, including major depression and anxiety disorders; the lifetimeoccurrence of substance is almost 50%.

Social problems, such as long-term unemployment, poverty and homelessness, are common.The average life expectancy of people with the disorder is 12 to 15 years less than thosewithout, the result of increased physical health problems and a higher suicide rate (about 5%).
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://en.wikipedia.org/wiki/Wikipedia:IPA_for_Englishhttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://en.wikipedia.org/wiki/Mental_disorderhttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://en.wikipedia.org/wiki/Auditory_hallucinationhttp://en.wikipedia.org/wiki/Auditory_hallucinationhttp://en.wikipedia.org/wiki/Paranoiahttp://en.wikipedia.org/wiki/Delusionhttp://en.wikipedia.org/wiki/Thought_disorderhttp://en.wikipedia.org/wiki/Prevalencehttp://en.wikipedia.org/wiki/Geneticshttp://en.wikipedia.org/wiki/Neurobiologyhttp://en.wikipedia.org/wiki/Psychologyhttp://en.wikipedia.org/wiki/Dissociative_identity_disorderhttp://en.wikipedia.org/wiki/Antipsychotichttp://en.wikipedia.org/wiki/Dopaminehttp://en.wikipedia.org/wiki/Serotoninhttp://en.wikipedia.org/wiki/Receptor_(biochemistry)http://en.wikipedia.org/wiki/Emergency_psychiatryhttp://en.wikipedia.org/wiki/Cognitionhttp://en.wikipedia.org/wiki/Comorbidityhttp://en.wikipedia.org/wiki/Major_depressive_disorderhttp://en.wikipedia.org/wiki/Anxiety_disorderhttp://en.wikipedia.org/wiki/Life_expectancyhttp://en.wikipedia.org/wiki/Life_expectancyhttp://en.wikipedia.org/wiki/Anxiety_disorderhttp://en.wikipedia.org/wiki/Major_depressive_disorderhttp://en.wikipedia.org/wiki/Comorbidityhttp://en.wikipedia.org/wiki/Cognitionhttp://en.wikipedia.org/wiki/Emergency_psychiatryhttp://en.wikipedia.org/wiki/Receptor_(biochemistry)http://en.wikipedia.org/wiki/Serotoninhttp://en.wikipedia.org/wiki/Dopaminehttp://en.wikipedia.org/wiki/Antipsychotichttp://en.wikipedia.org/wiki/Dissociative_identity_disorderhttp://en.wikipedia.org/wiki/Psychologyhttp://en.wikipedia.org/wiki/Neurobiologyhttp://en.wikipedia.org/wiki/Geneticshttp://en.wikipedia.org/wiki/Prevalencehttp://en.wikipedia.org/wiki/Thought_disorderhttp://en.wikipedia.org/wiki/Delusionhttp://en.wikipedia.org/wiki/Paranoiahttp://en.wikipedia.org/wiki/Auditory_hallucinationhttp://en.wikipedia.org/wiki/Auditory_hallucinationhttp://en.wikipedia.org/wiki/Mental_disorderhttp://en.wikipedia.org/wiki/Wikipedia:IPA_for_Englishhttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


11/47

Symptoms

A person diagnosed with schizophrenia may experience hallucinations (most reportedare hearing voices), delusions (often bizarre or persecutory in nature), and disorganized thinkingand speech.

The latter may range from loss of train of thought, to sentences only loosely connected inmeaning, to incoherence known as word salad in severe cases. Social withdrawal, sloppiness ofdress and hygiene, and loss of motivation and judgment are all common in schizophrenia.

There is often an observable pattern ofemotional difficulty, for example lack ofresponsiveness. Impairment in social cognition is associated with schizophrenia as aresymptoms ofparanoia;social isolation commonly occurs.

Difficulties in working and long-term memory,attention,executive functioning, and speedofprocessing also commonly occur. In one uncommon subtype, the person may be largelymute, remain motionless in bizarre postures, or exhibit purposeless agitation, all signsofcatatonia.

Late adolescence and early adulthood are peak periods for the onset of schizophrenia, criticalyears in a young adult's social and vocational development. In 40% of men and 23% of womendiagnosed with schizophrenia, the condition manifested itself before the age of 19.

To minimize the developmental disruption associated with schizophrenia, much work hasrecently been done to identify and treat the prodromal (pre-onset) phase of the illness, whichhas been detected up to 30 months before the onset of symptoms.

Those who go on to develop schizophrenia may experience transient or self-limiting psychoticsymptoms and the non-specific symptoms of social withdrawal, irritability, dysphoria, andclumsiness during the prodromal phase.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://en.wikipedia.org/wiki/Hallucinationhttp://en.wikipedia.org/wiki/Auditory_hallucinationhttp://en.wikipedia.org/wiki/Delusionhttp://en.wikipedia.org/wiki/Persecutory_delusionshttp://en.wikipedia.org/wiki/Thought_disorderhttp://en.wikipedia.org/wiki/Thought_disorderhttp://en.wikipedia.org/wiki/Schizophasiahttp://en.wikipedia.org/wiki/Emotionalhttp://en.wikipedia.org/wiki/Social_cognitionhttp://en.wikipedia.org/wiki/Paranoiahttp://en.wikipedia.org/wiki/Social_isolationhttp://en.wikipedia.org/wiki/Working_memoryhttp://en.wikipedia.org/wiki/Long-term_memoryhttp://en.wikipedia.org/wiki/Attentionhttp://en.wikipedia.org/wiki/Executive_functionshttp://en.wikipedia.org/wiki/Information_processinghttp://en.wikipedia.org/wiki/Catatoniahttp://en.wikipedia.org/wiki/Prodromehttp://en.wikipedia.org/wiki/Dysphoriahttp://en.wikipedia.org/wiki/Dysphoriahttp://en.wikipedia.org/wiki/Prodromehttp://en.wikipedia.org/wiki/Catatoniahttp://en.wikipedia.org/wiki/Information_processinghttp://en.wikipedia.org/wiki/Executive_functionshttp://en.wikipedia.org/wiki/Attentionhttp://en.wikipedia.org/wiki/Long-term_memoryhttp://en.wikipedia.org/wiki/Working_memoryhttp://en.wikipedia.org/wiki/Social_isolationhttp://en.wikipedia.org/wiki/Paranoiahttp://en.wikipedia.org/wiki/Social_cognitionhttp://en.wikipedia.org/wiki/Emotionalhttp://en.wikipedia.org/wiki/Schizophasiahttp://en.wikipedia.org/wiki/Thought_disorderhttp://en.wikipedia.org/wiki/Thought_disorderhttp://en.wikipedia.org/wiki/Persecutory_delusionshttp://en.wikipedia.org/wiki/Delusionhttp://en.wikipedia.org/wiki/Auditory_hallucinationhttp://en.wikipedia.org/wiki/Hallucinationhttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


12/47

Medications

Antipsychotic medications are the most effective treatment for schizophrenia. They change thebalance of chemicals in the brain and can help control symptoms.

These medications are usually helpful, but they can cause side effects. Many side effects can bemanaged, and they should not prevent you from seeking treatment for this serious condition.

Common side effects from antipsychotics may include:

Dizziness Feelings of restlessness or "jitters" Sleepiness (sedation) Slowed movements Tremor Weight gain

Long-term use of antipsychotic medications may increase your risk for a movement disordercalled tardive dyskinesia. This condition causes repeated movements that you cannot controlespecially around the mouth. Call your health care provider right away if you think you mayhave this condition.

When schizophrenia does not improve with several antipsychotics, the

medication clozapine can be helpful. Clozapine is the most effective medication for reducingschizophrenia symptoms, but it also tends to cause more side effects than other antipsychotics.

Schizophrenia is a life-long illness. Most people with this condition need to stay onantipsychotic medication for life.

The most common salt used for Schizophrenia treatment are

Amisulpride Olanzapine Risperidone Quetiapine
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000893/http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000893/http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000893/http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000893/http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


13/47

Amisulpride

Amisulpride (sold as Solian, Sulpitac, Amitrex, Soltus or Amazeo), is an atypicalantipsychotic used to treat psychosis in schizophrenia and episodes ofmania in bipolar disorder

In small doses it is also used to treat depression. It was introduced by Sanofi-Aventis in the1990s.Amisulpride is not approved for use in the United States.

Amisulpride, a substituted benzamide derivative, is a second-generation (atypical)antipsychotic. At low doses, it enhances dopaminergic neurotransmission by preferentiallyblocking presynaptic dopamine D2/D3 autoreceptors.

At higher doses, amisupride antagonises postsynaptic dopamine D2 and D3 receptors,preferentially in the limbic system rather than the striatum, thereby reducing dopaminergictransmission. In patients with acute exacerbations of schizophrenia, the recommended dosage ofamisulpride is 400 to 800 mg/day, although dosages < or =1200 mg/day may be administered.

In comparative trials, amisulpride administered within this range (400 to 1200 mg/day) was aseffective as haloperidol 5 to 40 mg/day, flupenthixol 25 mg/day and risperidone 8 mg/day inpatients with acute exacerbations of schizophrenia with predominantly positive symptomsAmisulpride was more effective than haloperidol but equally effective as risperidone incontrolling negative symptoms

Pharmacology

Amisulpride functions primarily as a D2and D3 receptor antagonist. It has high affinity for thesereceptors with dissociation constants of 2.8 nM and 3.2 nM, respectively. Although standarddoses in the 400 to 1200 mg a day range used totreat psychosis inhibit dopaminergic neurotransmission, low doses in the 50 to 200 mg rangepreferentially block inhibitory pre-synaptic autoreceptors. This results in a facilitation ofdopamine activity, and for this reason, low dose amisulpride has also been used to treat clinicaldepression.

Amisulpride and its relative sulpiride have been shown to bind to and activate the GHBreceptor at doses that are used for therapeutic purposes. Activation of the GHB receptor isknown to inhibit the release ofdopamine and even appears to have neuroleptic effects itself. Forthis reason it is believed that amisulpride and sulpiride's action at this receptor may contributeto their efficacy in treating psychosis. Another recent study concludes that amisulpride is anappropriate first-line treatment for the management of acute psychosis.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Psychosishttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Maniahttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Major_depressive_disorderhttp://en.wikipedia.org/wiki/Sanofi-Aventishttp://en.wikipedia.org/wiki/D2_receptorhttp://en.wikipedia.org/wiki/D2_receptorhttp://en.wikipedia.org/wiki/D2_receptorhttp://en.wikipedia.org/wiki/D3_receptorhttp://en.wikipedia.org/wiki/D3_receptorhttp://en.wikipedia.org/wiki/D3_receptorhttp://en.wikipedia.org/wiki/Receptor_antagonisthttp://en.wikipedia.org/wiki/Dissociation_constanthttp://en.wikipedia.org/wiki/Psychosishttp://en.wikipedia.org/wiki/Dopaminergichttp://en.wikipedia.org/wiki/Neurotransmissionhttp://en.wikipedia.org/wiki/Pre-synaptichttp://en.wikipedia.org/wiki/Autoreceptorhttp://en.wikipedia.org/wiki/Clinical_depressionhttp://en.wikipedia.org/wiki/Clinical_depressionhttp://en.wikipedia.org/wiki/Sulpiridehttp://en.wikipedia.org/wiki/GHB_receptorhttp://en.wikipedia.org/wiki/GHB_receptorhttp://en.wikipedia.org/wiki/Dopaminehttp://en.wikipedia.org/wiki/Dopaminehttp://en.wikipedia.org/wiki/GHB_receptorhttp://en.wikipedia.org/wiki/GHB_receptorhttp://en.wikipedia.org/wiki/Sulpiridehttp://en.wikipedia.org/wiki/Clinical_depressionhttp://en.wikipedia.org/wiki/Clinical_depressionhttp://en.wikipedia.org/wiki/Autoreceptorhttp://en.wikipedia.org/wiki/Pre-synaptichttp://en.wikipedia.org/wiki/Neurotransmissionhttp://en.wikipedia.org/wiki/Dopaminergichttp://en.wikipedia.org/wiki/Psychosishttp://en.wikipedia.org/wiki/Dissociation_constanthttp://en.wikipedia.org/wiki/Receptor_antagonisthttp://en.wikipedia.org/wiki/D3_receptorhttp://en.wikipedia.org/wiki/D2_receptorhttp://en.wikipedia.org/wiki/Sanofi-Aventishttp://en.wikipedia.org/wiki/Major_depressive_disorderhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Maniahttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Psychosishttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


14/47

Quetiapine

Quetiapine (branded as Seroquin, Quel, Pincalm, Qutpin-SR), is an atypicalantipsychotic approved for the treatment ofschizophrenia,bipolar disorder, and as an add-on totreat depression. Annual sales are approximately $5.7 billion worldwide, with $2.9 billion in theUnited States. The U.S. patent, which was set to expire in 2011, received a pediatric exclusivityextension which pushed its expiration to March 26, 2012.

Quetiapine fumarate is used to treat either schizophrenia or bipolar disorder. Some users haveeven reported a pleasant side effect that entails a numbing of or contraction of the tongue,especially in human males.

MEDICAL USES

Schizophrenia

It is debatable whether, as a class, typical or atypical antipsychotics are better. Both have equaldrop-out and symptom relapse rates when typicals are used at low to moderate dosages.

Bipolar disorder

In those with bipolar disorder, it is used for depressive episodes, acute manic episodes

associated with bipolar I disorder (as either monotherapy or adjunct therapyto lithium,valproate or lamotrigine), and maintenance treatment of bipolar I disorder (as adjuncttherapy to lithium or divalproex)

Alzheimer's

Quetiapine is ineffective in reducing agitation among people with Alzheimer's, whose usage ofthe drug once constituted 29% of sales. Quetiapine worsens cognitive functioning in the elderlywith dementia and therefore is not recommended.

Other

It is sometimes used off-label, often as an augmentation agent, to treat conditions suchas obsessive-compulsive disorder,post-traumatic stressdisorder, autism, alcoholism, borderline personality disorder, depression,Tourettesyndrome, and has been used by physicians as a sedative for those with sleepdisorders or anxiety disorders.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Typical_antipsychoticshttp://en.wikipedia.org/wiki/Atypical_antipsychoticshttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Bipolar_I_disorderhttp://en.wikipedia.org/wiki/Lithium_pharmacologyhttp://en.wikipedia.org/wiki/Valproic_acidhttp://en.wikipedia.org/wiki/Lamotriginehttp://en.wikipedia.org/wiki/Alzheimer%27shttp://en.wikipedia.org/wiki/Off-labelhttp://en.wikipedia.org/wiki/Obsessive-compulsive_disorderhttp://en.wikipedia.org/wiki/Post-traumatic_stress_disorderhttp://en.wikipedia.org/wiki/Post-traumatic_stress_disorderhttp://en.wikipedia.org/wiki/Autismhttp://en.wikipedia.org/wiki/Alcoholismhttp://en.wikipedia.org/wiki/Borderline_personality_disorderhttp://en.wikipedia.org/wiki/Major_depressive_disorderhttp://en.wikipedia.org/wiki/Tourette_syndromehttp://en.wikipedia.org/wiki/Tourette_syndromehttp://en.wikipedia.org/wiki/Sleep_disorderhttp://en.wikipedia.org/wiki/Sleep_disorderhttp://en.wikipedia.org/wiki/Anxiety_disorderhttp://en.wikipedia.org/wiki/Anxiety_disorderhttp://en.wikipedia.org/wiki/Sleep_disorderhttp://en.wikipedia.org/wiki/Sleep_disorderhttp://en.wikipedia.org/wiki/Tourette_syndromehttp://en.wikipedia.org/wiki/Tourette_syndromehttp://en.wikipedia.org/wiki/Major_depressive_disorderhttp://en.wikipedia.org/wiki/Borderline_personality_disorderhttp://en.wikipedia.org/wiki/Alcoholismhttp://en.wikipedia.org/wiki/Autismhttp://en.wikipedia.org/wiki/Post-traumatic_stress_disorderhttp://en.wikipedia.org/wiki/Post-traumatic_stress_disorderhttp://en.wikipedia.org/wiki/Obsessive-compulsive_disorderhttp://en.wikipedia.org/wiki/Off-labelhttp://en.wikipedia.org/wiki/Alzheimer%27shttp://en.wikipedia.org/wiki/Lamotriginehttp://en.wikipedia.org/wiki/Valproic_acidhttp://en.wikipedia.org/wiki/Lithium_pharmacologyhttp://en.wikipedia.org/wiki/Bipolar_I_disorderhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Atypical_antipsychoticshttp://en.wikipedia.org/wiki/Typical_antipsychoticshttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


15/47

Risperidone

Risperidone (Risperdal, and generics) is a dopamine antagonist of the second-

generation or atypical antipsychotic class

possessing antiserotonergic, antiadrenergic and antihistaminergic, which is mainly used to

treat schizophrenia (including adolescent schizophrenia), schizoaffective disorder, the mixed

and manic states associated with bipolar disorder, and irritability in people with autism. It is

associated with significant weight gain and metabolic problems, as well as tardive

dyskinesia and neuroleptic malignant syndrome. Risperidone and other antipsychotics also

increase the risk of death in patients with dementia. The drug was developed by Janssen-

Cilag and first released in 1994

Medical uses

Risperidone is used for the treatment ofschizophrenia,bipolar disorder and behavior problems

in people with autism. In autism, however, it does not improve conversational ability or social

skills, and does not appear to reduce obsessive behavior in most autistic people.

Due to its strong serotonin, dopaminergic, and adrenergic antagonism, risperidone was

approved by the United States Food and Drug Administration(FDA) in 1993 for the treatment

of schizophrenia. On August 22, 2007, risperidone was approved as the only drug agent

available for treatment of schizophrenia in youths, ages 13 17; it was also approved that same

day for treatment of bipolar disorder in youths and children, ages 10 17,joininglithium.

Risperidone contains the functional groups ofbenzisoxazole and piperidine as part of its

molecular structure.

In 2003, the FDA approved risperidone for the short-term treatment of the mixed and manic

states associated with bipolar disorder. In 2006, the FDA approved risperidone for the treatment

of irritability in children and adolescents with autism. The FDA's decision was based in part on

a study of autistic people with severe and enduring problems of violent meltdowns, aggression

and self-injury; risperidone is not recommended for autistic people with mild aggression andexplosive behavior without an enduring pattern. Like other atypical antipsychotics, risperidone

has also been used off-label for the treatment of anxiety disorders, such as obsessive-

compulsive disorder, severe, treatment-resistant depression with or

without psychotic features, Tourette syndrome, disruptive behavior disorders in children

and eating disorders, among others.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://en.wikipedia.org/wiki/Dopamine_antagonisthttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Antiserotonergichttp://en.wikipedia.org/wiki/Antiadrenergichttp://en.wikipedia.org/wiki/Antihistaminergichttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Schizoaffective_disorderhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Autismhttp://en.wikipedia.org/wiki/Weight_gainhttp://en.wikipedia.org/wiki/Tardive_dyskinesiahttp://en.wikipedia.org/wiki/Tardive_dyskinesiahttp://en.wikipedia.org/wiki/Neuroleptic_malignant_syndromehttp://en.wikipedia.org/wiki/Janssen-Cilaghttp://en.wikipedia.org/wiki/Janssen-Cilaghttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Autismhttp://en.wikipedia.org/wiki/Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/Lithium_pharmacologyhttp://en.wikipedia.org/wiki/Functional_grouphttp://en.wikipedia.org/wiki/Benzisoxazolehttp://en.wikipedia.org/wiki/Piperidinehttp://en.wikipedia.org/wiki/Off-labelhttp://en.wikipedia.org/wiki/Obsessive-compulsive_disorderhttp://en.wikipedia.org/wiki/Obsessive-compulsive_disorderhttp://en.wikipedia.org/wiki/Clinical_depressionhttp://en.wikipedia.org/wiki/Psychotic_depressionhttp://en.wikipedia.org/wiki/Tourette_syndromehttp://en.wikipedia.org/wiki/Eating_disorderhttp://en.wikipedia.org/wiki/Eating_disorderhttp://en.wikipedia.org/wiki/Tourette_syndromehttp://en.wikipedia.org/wiki/Psychotic_depressionhttp://en.wikipedia.org/wiki/Clinical_depressionhttp://en.wikipedia.org/wiki/Obsessive-compulsive_disorderhttp://en.wikipedia.org/wiki/Obsessive-compulsive_disorderhttp://en.wikipedia.org/wiki/Off-labelhttp://en.wikipedia.org/wiki/Piperidinehttp://en.wikipedia.org/wiki/Benzisoxazolehttp://en.wikipedia.org/wiki/Functional_grouphttp://en.wikipedia.org/wiki/Lithium_pharmacologyhttp://en.wikipedia.org/wiki/Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/Autismhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Janssen-Cilaghttp://en.wikipedia.org/wiki/Janssen-Cilaghttp://en.wikipedia.org/wiki/Neuroleptic_malignant_syndromehttp://en.wikipedia.org/wiki/Tardive_dyskinesiahttp://en.wikipedia.org/wiki/Tardive_dyskinesiahttp://en.wikipedia.org/wiki/Weight_gainhttp://en.wikipedia.org/wiki/Autismhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Schizoaffective_disorderhttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Antihistaminergichttp://en.wikipedia.org/wiki/Antiadrenergichttp://en.wikipedia.org/wiki/Antiserotonergichttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Dopamine_antagonisthttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


16/47

Olanzapine

Olanzapine (trade name Zyprexa or in combination with fluoxetine Symbyax) is an atypical

antipsychotic, approved by the FDA for the treatment of schizophrenia and bipolar

disorder. Olanzapine is structurally similar to clozapine, but is classified asa thienobenzodiazepine. The olanzapine formulations are manufactured and marketed by

the pharmaceutical company Eli Lilly and Company; the drug went generic in 2011

Medical uses

Oral formulation: acute and maintenance treatment of schizophrenia in adults, acute treatmentof manic or mixed episodes associated with bipolar I disorder (monotherapy and in combinationwith lithium or valproate)

Intramuscular formulation like Zyprexa IntraMuscular: acute agitation associated withschizophrenia and bipolar I mania in adults.

Oral formulation combined with fluoxetine: treatment of acute depressive episodes associated

with bipolar I disorder in adults, or treatment of acute, resistant depression in adults

FDA approved uses

Treatment of the manifestations of psychotic disorders (September 1996 - March 2000).

Short-term treatment of acute manic episodes associated with bipolar I disorder (March 2000)

Short term treatment of schizophrenia instead ofthe management of the manifestations of

psychotic disorders (March 2000)

Treatment in combination with fluoxetine of depressive episodes associated with bipolar

disorder (December 2003)
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://en.wikipedia.org/wiki/Fluoxetinehttp://en.wikipedia.org/wiki/Symbyaxhttp://en.wikipedia.org/wiki/Symbyaxhttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Clozapinehttp://en.wikipedia.org/wiki/Thienobenzodiazepinehttp://en.wikipedia.org/wiki/Pharmaceutical_companyhttp://en.wikipedia.org/wiki/Eli_Lilly_and_Companyhttp://en.wikipedia.org/wiki/Lithiumhttp://en.wikipedia.org/wiki/Valproatehttp://en.wikipedia.org/wiki/Fluoxetinehttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Fluoxetinehttp://en.wikipedia.org/wiki/Bipolar_I_disorderhttp://en.wikipedia.org/wiki/Fluoxetinehttp://en.wikipedia.org/wiki/Valproatehttp://en.wikipedia.org/wiki/Lithiumhttp://en.wikipedia.org/wiki/Eli_Lilly_and_Companyhttp://en.wikipedia.org/wiki/Pharmaceutical_companyhttp://en.wikipedia.org/wiki/Thienobenzodiazepinehttp://en.wikipedia.org/wiki/Clozapinehttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Bipolar_disorderhttp://en.wikipedia.org/wiki/Schizophreniahttp://en.wikipedia.org/wiki/Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Atypical_antipsychotichttp://en.wikipedia.org/wiki/Symbyaxhttp://en.wikipedia.org/wiki/Fluoxetinehttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


17/47

CHAPTER-2


18/47

2.LITERATURE REVIEW


19/47

The effects of amisulpride on five dimensions of psychopathology in patients with

schizophrenia: a prospective open- label study

Miguel Herrera-Estrella Date: 3 may 2005

Background

The treatment of schizophrenia has shown important improvements since the introduction of

new antipsychotics. These drugs, also called atypical or second generation antipsychotics

(SGAs) bring the possibility of a better quality of life for patients affected with schizophrenia

because they have been associated with a better efficacy over negative symptoms, probably less

cognitive impairment and lower probability of extrapyramidal symptoms (EPS) , which is one

of their main advantages.

The SGAs increase the release of dopamine in the prefrontal cortex and the hippocampus. This

effect of SGAs is critical to improve negative symptoms and cognition, and to decrease the

EPS. The principal hypothesis of their mechanism of action has been attributed to the

antagonism of 5-HT2A receptors coupled to weaker antagonism of dopamine D2 receptors

Their effect as 5-HT1A receptor agonist has also been suggested to contribute to an atypical

antipsychotic profile.

Nevertheless, amisulpride represents an important contrast on the theory of the 5HT2A receptor

antagonism. Amisulpride, is a benzamide with high affinity for dopamine D2 and D3 receptors

without affinity for serotonin, muscarinic or alpha-adrenergic receptors Amisulpride also shows

selectivity for dopamine receptors in limbic and hippocampal structures, rather than striatal

region.

At low doses (100 300 mg/d), amisulpride binds preferentially on D2/D3 presynaptic

autoreceptors, increasing dopaminergic transmission in the prefrontal cortex, which is believed

to be associated with improvement of primary negative symptoms. Doses between 400 800

mg/d result in antagonism of postsynaptic dopamine receptors, leading to an improvement of

positive symptoms of schizophrenia with less EPS development.


20/47

The limbic selectivity of amisulpride is similar to the observed with clozapine, and is secondary

to its high affinity for D3 receptors and the short isoform of the D2 receptor, which are highly

distributed in these regions . This selectivity has been documented in animal models. In

addition, PET studies have shown that receptor D2 occupancy in striatal regions is around 14%

when amisulpride is prescribed at doses between 50 100 mg/d.A decreased amisulpride plasma

concentration induces a low percentage of occupancy in striatal and increased occupancy in

limbic regions.

The improvement of negative symptoms has been documented in clinical studies with doses

between 50 100 mg/d. Until now, amisulpride is the only antipsychotic that has shown

scientific evidence of its efficacy over the primary negative symptoms of schizophrenia .Several clinical trials have shown that amisulpride has similar efficacy and better tolerability in

comparison to haloperidol and flupentixol as well as similar efficacy and safety when compared

to olanzapine and risperidone . Additionally, amisulpride has shown a positive effect over

depressive symptoms and the cognitive impairment related to schizophrenia.

These data support that amisulpride is also an 'atypical' antipsychotic despite having a different

receptor-affinity profile. However, there is a lack of studies about the efficacy and tolerabilityof amisulpride in latin populations. We decided to perform a 3-month open trial to determine

these parameters on a sample of Mexican patients, using the five-factor model of schizophrenic

psychopathology, a previously determined useful strategy for the evaluation of drug efficacy.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


21/47

A review of the pharmacokinetics, tolerability and pharmacodynamics of

amisulpride in healthy volunteers.

P. Rosenzweig*, M. Canal Date:23 JAN 2002

Amisulpride binds selectively to dopamine D2 and D3 receptors in the limbic system. Low

doses of amisulpride preferentially block presynaptic D2/D3-dopamine autoreceptors, thereby

enhancing dopaminergic transmission, whereas higher doses block postsynaptic receptors, thus

inhibiting dopaminergic hyperactivity. Amisulpride is clinically effective on the negative

symptoms of acute schizophrenia exacerbations at low dosages (50 300 mg/day), and also on

the positive symptoms of the disease at high dosages (400 800 mg/day).

Nineteen clinical studies involving 358 volunteers have investigated the pharmacokinetics

pharmacodynamics and tolerability of amisulpride. Amisulpride shows linear pharmacokinetics,

a bioavailability of 48%, low protein binding (17%) and an elimination half-life of12 h. It is

predominantly eliminated in the urine as the parent compound. It exhibits no significant

detrimental effects in psychometric or memory tests up to the dose of 400 mg/day, inducing

only mild impairment at high doses, whereas EEG data suggest an alertness-enhancing effect at

low doses ( 50 mg).

Moreover, amisulpride does not potentiate the depressant effects on the central nervous system

of alcohol and lorazepam. This tolerability profile is clearly better than that of haloperidol

4 mg/day and is consistent with a weak blocking effect on striatal D2 receptors. In summary

studies in humans have shown that amisulpride is free of behavioural toxicity at doses exerting

clear antipsychotic efficacy and confirm that its CNS effects may vary with the dose

administered. Copyright 2002 John Wiley & Sons, Ltd.


22/47

Second-Generation (Atypical) Antipsychotics and Metabolic Effects. A

Comprehensive Literature Review

Newcomer, John W. CNS Drugs, Volume 19, 2005, pp. 1-93(93)

Increasing numbers of reports concerning diabetes, ketoacidosis, hyperglycaemia and lipid

dysregulation in patients treated with second-generation (or atypical) antipsychotics have raised

concerns about a possible association between these metabolic effects and treatment with these

medications. This comprehensive literature review considers the evidence for and against an

association between glucose or lipid dysregulation and eight separate second-generation

antipsychotics currently available in the US and/or Europe, specifically clozapine, olanzapine,

risperidone, quetiapine, zotepine, amisulpride, ziprasidone and aripiprazole. This review also

includes an assessment of the potential contributory role of treatment-induced weight gain in

conferring risk for hyperglycaemia and dyslipidaemia during treatment with different

antipsychotic medications.

Substantial evidence from a variety of human populations, including some recent confirmatory

evidence in treated psychiatric patients, indicates that increased adiposity is associated with a

variety of adverse physiological effects, including decreases in insulin sensitivity and changes

in plasma glucose and lipid levels. Comparison of mean weight changes and relative

percentages of patients experiencing specific levels of weight increase from controlled,randomised clinical trials indicates that weight gain liability varies significantly across the

different second generation antipsychotic agents. Clozapine and olanzapine treatment are

associated with the greatest risk of clinically significant weight gain, with other agents

producing relatively lower levels of risk. Risperidone, quetiapine, amisulpride and zotepine

generally show low to moderate levels of mean weight gain and a modest risk of clinically

significant increases in weight. Ziprasidone and aripiprazole treatment are generally associated

with minimal mean weight gain and the lowest risk of more significant increases.

Published studies including uncontrolled observations, large retrospective database analyses andcontrolled experimental studies, including randomised clinical trials, indicate that the different

second-generation antipsychotics are associated with differing effects on glucose and lipid

metabolism. These studies offer generally consistent evidence that clozapine and olanzapine

treatment are associated with an increased risk of diabetes mellitus and dyslipidaemia.

Inconsistent results, and a generally smaller effect in studies where an effect is reported, suggest

limited if any increased risk for treatment-induced diabetes mellitus and dyslipidaemia during

risperidone treatment, despite a comparable volume of published data. A similarly smaller and
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.ingentaconnect.com/content/adis/cnshttp://www.ingentaconnect.com/content/adis/cnshttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


23/47

inconsistent signal suggests limited if any increased risk of diabetes or dyslipidaemia during

quetiapine treatment, but this is based on less published data than is available for risperidone

The absence of retrospective database studies, and little or no relevant published data from

clinical trials, makes it difficult to draw conclusions concerning risk for zotepine or

amisulpride, although amisulpride appears to have less risk of treatment-emergent

dyslipidaemia in comparison to olanzapine. With increasing data from clinical trials but little or

no currently published data from large retrospective database analyses, there is no evidence atthis time to suggest that ziprasidone and aripiprazole treatment are associated with an increase

in risk for diabetes, dyslipidaemia or other adverse effects on glucose or lipid metabolism.

In general, the rank order of risk observed for the second-generation antipsychotic medications

suggests that the differing weight gain liability of atypical agents contributes to the differing

relative risk of insulin resistance, dyslipidaemia and hyperglycaemia. This would be consistent

with effects observed in nonpsychiatric samples, where risk for adverse metabolic changes

tends to increase with increasing adiposity. From this perspective, a possible increase in risk

would be predicted to occur in association with any treatment that produces increases in weight

and adiposity.

However, case reports tentatively suggest that substantial weight gain or obesity may not be a

factor in up to one-quarter of cases of new-onset diabetes that occur during treatment. Pending

further testing from preclinical and clinical studies, limited controlled studies support the

hypothesis that clozapine and olanzapine may have a direct effect on glucose regulation

independent of adiposity. The results of studies in this area are relevant to primary and

secondary prevention efforts that aim to address the multiple factors that contribute to increasedprevalence of type 2 diabetes mellitus and cardiovascular disease in populations that are often

treated with second-generation antipsychotic medications.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


24/47

Antipsychotic medication, functional outcome and quality of life in schizophrenia: focus

on amisulpride.

Nuss P, Tessier C. Date:2010 Apr

Only one dedicated study assessing functional outcome or quality of life as a primary outcome

criterion was identified. This demonstrated significant improvement in subjective well-being in

patients with schizophrenia initiating treatment with amisulpride, and a correlation between this

improvement and amelioration of psychopathology. In addition, functional outcome rating

scales were used as secondary outcome measures in eight randomised clinical trials, and two

naturalistic observational studies. Amisulpride treatment was associated with improvement in

functional outcome, with effect sizes that were comparable between studies. Improvements in

functional outcome are consistently greater than those observed in patients treated withhaloperidol and similar in magnitude to those seen with three other atypical antipsychotics,

namely olanzapine, ziprasidone and risperidone. A patient-reported outcome measure was used

in only one comparative study, and demonstrated perception of a superior benefit with

amisulpride compared to haloperidol. These findings could to some extent be replicated in

several large naturalistic studies under standard conditions of care.

The data from studies on functional outcome and subjective well-being provide consistent

information supporting the use of amisulpride for the treatment of schizophrenia in order to

improve social functioning, integration into the community and autonomy, which are critical forthe overall quality of life of patients with schizophrenia.


25/47

Treatment of negative symptoms in schizophrenia by amisulpride

Plissolo A, Krebs MO, Oli JP Date:1996 May-JunThe deficit forms of schizophrenia have given rise to important research and controversy for the

last 15 years. It is now recognized that some negative symptoms in schizophrenia are part of apure and primary deficit syndrome which could be related to decreased dopaminergic function

and which is not well improved by standard antipsychotic drugs. Amisulpride is a substituted

benzamide neuroleptic with an original pharmacologic profile. Prescription of high doses (600-

1 200 mg/day) yields to an usual antipsychotic activity on positive symptoms, through the

blockage of post-synaptic dopamine receptors. At low doses, amisulpride preferentially blocks

presynaptic dopamine autoreceptors, with a poor affinity for striatal sites. Three recent double-

blind placebo controlled studies have suggested an efficacy of low doses (50-300 mg/day) of

amisulpride in deficit forms of schizophrenia. The first study was carried out in young never-

treated schizophrenic patients, and showed a significant improvement of negative symptoms

with a 6-week amisulpride treatment. In the second study, subjects with a long-course deficit

schizophrenia were included after a 6-week wash-out period. Reduction of scores of negative

symptoms (Andreasen's scale) was about twice as important in the amisulpride group compared

to the placebo group, whereas positive symptoms, modest at inclusion, remained unchanged.

Finally, the efficacy of amisulpride was shown in another double-blind long-term study over 6

months in patients with predominantly negative symptoms. The overall safety profile of

amisulpride in these studies was good, in particular with a low incidence of extrapyramidal

symptoms. Thus, amisulpride at low doses appeared to be a well tolerated treatment for various

deficit forms of schizophrenia, with a short-term and long-term efficacy.


26/47

CHAPTER-3


27/47

3. Objective of study

3.1 SCOPE OF STUDY

The scope of this project is to understand and describe the factors which would play major role

in market acceptance of Solian. Amisulpride is one of the foremost amongst future economy

drivers. It is committed to deliver high quality drugs and formulation at an affordable price for

the general public, so that majority of people can afford it. The report also gives a realistic

picture of the strengths and limitations of the solian, indicating those product groups whose

strengths are set to last.

SPECIFIC OBJECTIVE

PERCEPTIONS OF DOCTORS ABOUT SOLIAN (AMISULPRIDE) FOR THE

TRAETMENT OF SCHIZOPHRENIA

3.1 SUB OBJECTIVE

To study the perception of doctors about solian drugs when other molecules are also present forthe treatment of schizophrenia..

To study problems faced by solian in market acceptance. To comparative study about the solian with other similar drugs available in the market.


28/47

CHAPTER 4


29/47

4.1 RESEARCH DESIGN

There is a huge array of alternative research designs that can satisfy research objectives. The

key is to create a design that enhances the value of the information obtained, whilst reducing

the cost of obtaining it.

Marketing research can be classified one of three categories:

1. Exploratory research

2. Conclusive research :

a) Descriptiveresearch

b) Causal research

These classifications are made according to the objective of the research. In some cases theresearch will fall into one of these categories, but in other cases different phases of the sameresearch project will fall into different categories.

1.Exploratory research has the goal of formulating problems more precisely, clarifyingconcepts, gathering explanations, gaining insight, eliminating impractical ideas, and

forming hypotheses. Exploratory research can be performed using a literature search,surveying certain people about their experiences, focus groups, and case studies.When surveying people, exploratory research studies would not try to acquire arepresentative sample, but rather, seek to interview those who are knowledgeable andwho might be able to provide insight concerning the relationship among variables. Casestudies can include contrasting situations or benchmarking against an organizationknown for its excellence. Exploratory research may develop hypotheses, but it doesnot seek to test them. Exploratory research is characterized by its flexibility.

2. Conclusive research is the research design which leads us to conclusion. It isclassified into:a) Descriptive research.b) Causal research


30/47

a)Descriptive research is more rigid than exploratory research and seeks todescribe users of a product, determine the proportion of the population that uses a

product, or predict future demand for a product. As opposed to exploratory research,

descriptive research should define questions, people surveyed, and the method ofanalysis prior to beginning data collection. In other words, the who, what, where,

when, why, and how aspects of the research should be defined. Such preparation

allows one the opportunity to make any required changes before the costly process

of data collection has begun.

There are two basic types of descriptive research: longitudinal studies and cross-

sectional studies. Longitudinal studies are time series analyses that make repeated

measurements of the same individuals, thus allowing one to monitor behavior

such as brand-switching. However, longitudinal studies are not necessarily

representative since many people may refuse to participate because of the

commitment required. Cross- sectional studies sample the population to make

measurements at a specific point in time. A special type of cross-sectional

analysis is a cohort analysis, which tracks an aggregate of individuals who

experience the same event within the same time interval over time. Cohort analyses

are useful for long-term forecasting of product demand.

b) Causal research seeks to find cause and affect relationships between variables. It

accomplishes this goal through laboratory and field experiments.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


31/47

Research Design Used in the Project-

Descriptive format of conclusive research.

Data Collection

Sampling Procedure: Doctors (Psychiatrist).

Primary data: It was collected through well structured questionnaire from

Doctors. The questionnaire design was such that it motivated the respondents to cooperate,

become involved, and provide complete, Honest and accurate answers.

Secondary Data: It includes information obtained from literature review, articles in the

Newspapers, magazines and internet.

Data Presentation-It is based on statistical analysis of the feedbacks obtained.

vResearch Duration:60 DaysvTime line

No: of days Line of action

10 Secondary research

5 Questionnaires Designing

30 Field work

15 Report preparation

vResearch Design: Exploratory ResearchvSampling Frame: Psychiatrist Doctor svSampling Size:150vResearch Location: DelhivResearch instrument: Questionnaires (open ended)vMode of data collection: One to One interview and Discussion

.


32/47

4.2 LIMITATIONS

v In-depth interviews only with the Doctors who were ready to give appointments..vDeviation from the topic.vSnowballing effect resulted in unnecessary discussions.vNot easy to get appointments.vEntries in Hospitals, without appointments were not allowed.vOnly point of view, of Doctors is taken.
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22


33/47

4.3 QUESTIONNAIRE DESIGN

Date:

Name: ADNAN EJAZ

Your opinion matters!

PERSONAL DETAILS:

Doctor:

Contact no.

Place:

Q.1 In Schizophrenia, the molecules you prefer, kindly rank?

Olanzapine Amisulpride Risperidone Quetiapine

Q.2. In Amisulpride which brand you prefer?

Q.3. Have you tried Solian for your patient of Schizophrenia?

Yes No

Q.4 What comes in your top of the mind, when it comes to solian?

Positive Symptoms Negative Symptoms Add on Acute Psychosis Early intervention


34/47

Q.5 What characteristics differentiate Solian from competition. How is it set apart from competing brands?

Value added CMES Quality Representation from Sanofi

Efficacy & Safety of brand

Q.6 What do you think Solian as a brand of Amisulpride molecules?

Excellent Product Very Good Product Good Product Average Product Poor Product

Q.7 How and what does Solian communicate instantly?

Sustained Symptom Control Lower Risk Of Side Effects Improve Functioning Towards a new beginning

Q.8 What are the factor that gives you more confidence to Rx Solian to more patients?

..

..

Q.9 Do you want Sanofi to represent in your clinic?

Preferred Day:

Preferred Time:

Thank you


35/47

CHAPTER-5


36/47

DATA ANALYSIS AND

FINDINGS FROM INDEPTH

INTERVIEWS


37/47

TOTAL NUMBER OF SAMPLES.

FINDINGS:

Total number of sample are 145. Out of which 80 Psychiatrist responded constituting to 55% of response and

remaining 45% turned out to be non-responder.

The data would have been more accurate, meaningful and statistically significant ifthe response rate was higher.

RESPONSE

55%

NON- RESPONSE

45%

TOTAL NUMBER OF DOCTORS


38/47

Q1. In Schizophrenia, the molecules you prefer, kindly rank?

FINDINGS:

Among four molecules, Olanzapin is the most preferred molecule for the treatment ofschizophrenia.

The survey shows that the molecule Amisulpride comes under top 3 sellingmolecules by the doctors for the treatment of schizophrenia.

Other molecules preffered for the treatment are Resperidone and Quetiapine

0

10

20

30

40

50

60

OLANZAPINE RESPERIDONE AMISULPRIDE QUETIAPINE

OLANZAPINE 47 Rank 1

RESPERIDONE 40 Rank 2

QUETIAPINE 60 Rank 3

AMISULPRIDE 60 Rank 3


39/47

Q.2. In Amisulpride which brand you prefer?

FINDINGS:

When surveyed thoroughly, it is found that Solian is the most preferred brand thatuse Amisulpride molecule.

The brand Solian is registered product from Sanofi. Other preferred brands for Amisulpride molecules are namely Sulpitac and Amigold

leading in the market. They represent big names in the market such as Lupin and Sun

Pharma.

The survey clearly puts Solian as a leading brand among all with 35% practitionerrecommending it and this is followed by Sulpitac with 22% and Amigold 11% and

few of them preferring others like Generic brands, Ampride, Soltus and Sulpride.

About 24% of practitioners did not want to reveal their preferred brand. Sanofi leads ahead of Lupin and Sun Pharma and constitute major player in the field.

SOLIAN

35%

SULPITAC

22%

AMIGOLD

11%

SOLTUS

6%

GENERIC

6%

AMPRIDE

1%

SULPRIDE

1%

NO COMMENTS

18%

PREFFERD BRANDS


40/47

Q.3. Have you tried Solian for your patient of Schizophrenia?

FINDINGS:

The survey shows that all practitioners and doctors are well aware of the existence ofbrand Solian as one of the treatment option for schizophrenic patients.

The result shows that more than 90% of doctors have tried Solian on their patients forthe treatment of subsets of schizophrenia.

There is awareness of brand and the product among the doctors makes Solian as aproduct which holds positive aspect for the future growth and progress in the market.

YES

94%

NO

6%

NUMBER OF DOCTORS TRIED SOLIAN


41/47

Q.4 What comes in your top of the mind, when it comes to solian?

FINDINGS: When asked about the functional aspect of Solian, there were mixed responses from

the field regarding its usage.

32% of the practitioners said that Solian is mainly used for negative symptoms in thetreatment of schizophrenia

Positive symptoms and add on are the some other areas where solian is alsoprescribed.

Acute Psychosis and Early intervention symptoms are the area where solian have towork really hard to acquire all the segment of the market for the treatment of

schizophrenia.

NEGATIVE SYMPTOMS

32%

POSITIVE SYMPTOMS

27%

ADD ON

24%

ACUTE PSYCHOSIS

12%

EARLY

INTERVENTION

5%

SOLIAN MAINLY USED FOR


42/47

Q.5 What characteristics differentiate Solian from competition? How

is it set apart from competing brands?

FINDINGS:

Quality of the product is the main characteristic that differentiate Solian from itscompeting brands.

Value added CME s are the second most preferred factor that differentiates solianfrom its competing brand.

Representation from a big pharma name like Sanofi add value to Solian and give it anedge over other prevailing brands in the market.

Safety and Efficacy of brand comes under the quality category.

QUALITY

33%

VALUE ADDED CME'S

28%

RESPRESENTATION

FROM SANOFI25%

EFFICACY &

SAFETY OF BRAND

14%

DIFFERENT CHARACTERISTIC OF SOLIAN FROM

COMPETITION


43/47

Q.7 How and what does Solian communicate instantly?

FINDINGS:

When surveyed for Solian about its mode of action and other associated factors, thefinding has an impressive result.

Solian is mainly picked up by doctors owing to its lower risk of side effects whichaccounts for its success. The lower side effect is one of the major criteria for any

drug to be included and prevail in the course of treatment where Solian scored

maximum response.

Besides, Solian is also found to be effective in treatment owing to its improvefunctioning and sustained symptoms control.

SUSTAINED SYMPTOM

CONTROL

25%

LOWER RISK OF SIDE

EFFECTS

39%

IMPROVE

FUNCTIONING

33%

TOWARDS A

NEW

BEGINNING

3%

SOLIAN COMMUNICATES INSTANTLY


44/47

Q.8 What are the factor that gives you more confidence to Rx Solian

to more patients?

FINDINGS:

When asked about the overall factors contributing to Solian for giving it an edge overother products running in the market, the response comes out to be satisfying in all

necessary areas of consideration.

The major factor contributing to Solian success is its Quality comes first inconsideration.

The other majorimportant considerations are its Less Side Effect followed byEvidence Based, Safety Issues and Improve Functioning over other similar

products.

28

21

14

4 4 3

QUALITY LESS SIDE EFFECT EVIDENCE BASE SAFETY OF

PRODUCT

IMPROVE

FUNCTIONING

IMPROVE -VE

SYMPTOMS

FACTORS TO Rx SOLIAN

FACTORS TO Rx SOLIAN


45/47

CONCLUSION

Amisulpride is currently being used as one of the potent molecule for the treatment of

schizophrenia as it is clinically effective on various symptoms of this acute disease. Exhibitingno detrimental effect even at the high dose makes it one of the favorite molecules currentlybeing employed in the area. Owing to its strong clinical relevance background with significantviable clinical human trials, we decided to study its hold in the current market focusing onvarious factors it associated with it. Amisulpride is currently being available as a brand nameSolian under the banner of Sanofi-Aventis, a leading pharmaceutical company of the world. Tohave a realistic picture we decided to conduct a survey in and around the area of NationalCapital Region of Delhi among different doctors/practitioners to express their views on Solianfor the treatment of schizophrenic patients. The questionnaire was prepared keeping in mind

about various issues that a new drug can face while being employed for treatment, focussingmajorly on its ability to act on subject and perceptions associated with it. The final aim was tohighlight the areas where Solian is facing problem in market acceptance and the comparativestudy with other drugs to further improve its availability and launching strategies.

In the first response where choosing a molecule for the treatment of schizophrenia is concerned,the first name that comes into the practitioner s mind is Olanzapin followed by ResperidoneThis clearly shows that Amisulpride is not one of the favorite molecule that is considered forthis treatment. Being at spot third among other molecules, it clearly shows that furtherawareness about the effectiveness of this molecule has to be highlighted. This can be done by

including more human clinical trials (already done or currently being done), research studiesand highlighting the advantageous features over others. But when it comes to choose a brandwithin Amisulpride, Solian is the first name that strikes in their mind which states its cleardominance in the category of this molecule. The other brand falling under this molecule areSulpitac and Amigold which are leading in the market representing big pharma names such asLupin and Sun Pharma. This depits the picture that Solian has to maintain its effectivenessunder all categories failing to which it may succumb to its rival brand. In order to do so, themarketing value, pricing slot and proper launch in wide spectrum of Solian has to be maintainedforeseeing all factors.

The survey result shows that all practitioners and doctors are well aware of Solian as thetreatment option for schizophrenic patients making it as one of the favorite brand. Theawareness and knowledge of this brand among the doctors makes Solian as a product whichholds positive aspect for the future growth and progress in the market. Therefore we need tomore focus on its stable availability globally even making them within the reach of remote areasby consulting doctors, holding meetings, conducting surveys with proper presentations with andamong experts in the field. We have surveyed and seen that the quality of the product is themain characteristics which differentiate Solian from its competing brands.


46/47

Besides, value added CME s and representation from a big pharma name such as Sanofi-Aventis add value to Solian giving it an edge over other prevailing brands in the market. AlsoSolian is found to be mainly the reason of choice among doctors due to the least side effect ifoffers where safety and efficacy of a drug play a major role. Overall Solian is the leading brand

among all Amisulpride molecule currently in the market according to this research surveyHowever this finding open a new window of opportunities to enhance its strength in the area bycreating more awareness about its positive role, more research analysis, systematic surveys,comparative analysis among its competing brands, availability in global spectrum, long termeffectiveness and strategic marketing approach in current level playing field.


47/47

REFRENCES

wikipedia.com google.com http://www.netdoctor.co.uk/brain-and-nervous-system/medicines/solian.html http://journals.lww.com/intclinpsychopharm/Abstract/2004/03000/A_double_blind,_rand

omized_comparative_trial_of.2.aspx

http://www.drugsupdate.com/brand/showavailablebrands/709 http://www.sanofipasteur.in/ www.sanofi.com www.sanofi-aventis.in http://onlinelibrary.wiley.com/doi/10.1002/hup.320/abstract http://www.ncbi.nlm.nih.gov/pubmed/20121655 http://www.ingentaconnect.com/content/adis/cns/2005/00000019/a00101s1/art00001 http://www.ncbi.nlm.nih.gov/pubmed/8767050 Through questionnaires presented before doctors and responses there from. Personal interview
http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22http://journals.lww.com/intclinpsychopharm/Abstract/2004/03000/A_double_blind,_randomized_comparative_trial_of.2.aspxhttp://journals.lww.com/intclinpsychopharm/Abstract/2004/03000/A_double_blind,_randomized_comparative_trial_of.2.aspxhttp://www.ncbi.nlm.nih.gov/pubmed/8767050http://www.sanofi-aventis.in/http://www.sanofi.com/http://www.sanofipasteur.in/http://www.drugsupdate.com/brand/showavailablebrands/709http://journals.lww.com/intclinpsychopharm/Abstract/2004/03000/A_double_blind,_randomized_comparative_trial_of.2.aspxhttp://journals.lww.com/intclinpsychopharm/Abstract/2004/03000/A_double_blind,_randomized_comparative_trial_of.2.aspxhttp://www.netdoctor.co.uk/brain-and-nervous-system/medicines/solian.htmlhttp://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22

summer trainning sanofi final

Documents