MedPath

Amisulpride

Generic Name
Amisulpride
Brand Names
Barhemsys
Drug Type
Small Molecule
Chemical Formula
C17H27N3O4S
CAS Number
71675-85-9
Unique Ingredient Identifier
8110R61I4U
Background

Amisulpride is a benzamide derivative and a dopamine receptor antagonist that selectively works on dopamine D2 and D3 receptors. As an antipsychotic agent, amisulpride alleviates both positive and negative symptoms of schizophrenia, and it exhibits antidepressant properties in patients with psychiatric disorders, dysthymia, and major depression. Amisulpride predominantly works in the limbic system, which explains its relatively lower risk of extrapyramidal adverse effects compared to other atypical antipsychotic agents. Oral tablets of amisulpride is used in European countries as a treatment for acute and chronic schizophrenic disorders, as well as secondary negative symptoms in mental health disorders such as affective disorders, depressive mood, and mental retardation.

Amisulpride is also used as an antiemetic agent. In the US, the intravenous formulation of amisulpride is used to treat and prevent postoperative nausea and vomiting in adults, either as monotherapy or in combination with another antiemetic agent of a different drug class. It is marketed under the brand name Barhemsys.

Indication

Intravenous amisulpride is indicated in adults for the prevention of postoperative nausea and vomiting, either alone or in combination with an antiemetic of a different class. It is also indicated for the treatment of postoperative nausea and vomiting in patients who have received anti-emetic prophylaxis with an agent of a different class or have not received prophylaxis.

Oral amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, characterized by positive symptoms with delusions, hallucinations, thought disorders, hostility and suspicious behavior; or primarily negative symptoms (deficit syndrome) with blunted affect, emotional and social withdrawal. Amisulpride also controls secondary negative symptoms in productive conditions as well as affective disorders such as depressive mood or retardation.

Associated Conditions
Acute Schizophrenia, Chronic Schizophrenia, Negative Symptoms, Post Operative Nausea and Vomiting (PONV)

Amisulpride Augmentation in Clozapine-unresponsive Schizophrenia

Phase 4
Completed
Conditions
Schizophrenia
Interventions
Drug: placebo
First Posted Date
2010-11-23
Last Posted Date
2015-04-01
Lead Sponsor
Imperial College London
Target Recruit Count
69
Registration Number
NCT01246232
Locations
🇬🇧

Imperial College London, London, United Kingdom

🇬🇧

University College London, London, United Kingdom

🇬🇧

University of Manchester, Manchester, United Kingdom

Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer

First Posted Date
2010-08-20
Last Posted Date
2010-08-20
Lead Sponsor
Chonbuk National University Hospital
Target Recruit Count
80
Registration Number
NCT01185418
Locations
🇰🇷

Chonbuk national university hospital, Jeonju, Korea, Republic of

Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism

Not Applicable
Completed
Conditions
Diabetes
Schizophrenia
Insulin Resistance
Interventions
Procedure: Glucose clamp technique
Drug: Placebo
First Posted Date
2010-07-13
Last Posted Date
2010-08-03
Lead Sponsor
Central Institute of Mental Health, Mannheim
Target Recruit Count
10
Registration Number
NCT01160991
Locations
🇩🇪

Central Institute of Mental Health, Mannheim, Germany

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

Not Applicable
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2010-07-01
Last Posted Date
2016-05-26
Lead Sponsor
University of Copenhagen
Target Recruit Count
136
Registration Number
NCT01154829
Locations
🇩🇰

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup, Glostrup, Denmark

Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients

Phase 4
Completed
Conditions
Treatment-resistant Schizophrenia
Interventions
Drug: Placebo add-on
First Posted Date
2010-04-16
Last Posted Date
2010-04-16
Lead Sponsor
National Health Research Institutes, Taiwan
Target Recruit Count
273
Registration Number
NCT01105481
Locations
🇨🇳

Departments of Psychiatry, Tao-yuan Psychiatric Center, Tao-Yuan, Taiwan

🇨🇳

Bali Psychiatric Center, Taipei County, Taiwan

Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

Not Applicable
Completed
Conditions
Metabolic Syndrome X
Interventions
First Posted Date
2009-08-11
Last Posted Date
2013-01-03
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
132
Registration Number
NCT00956189
Locations
🇨🇳

Yu-Li Hospital, Yu-Li, Hualien County, Taiwan

🇨🇳

Yu-Li Veterans Hospital, Yu-Li, Hualien County, Taiwan

🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Tardive Dyskinesia and Cognitive Function

Phase 4
Completed
Conditions
Tardive Dyskinesia
Neurocognitive Function
Interventions
Drug: Conventional antipsychotics
First Posted Date
2009-06-24
Last Posted Date
2009-06-24
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Target Recruit Count
80
Registration Number
NCT00926965
Locations
🇨🇳

Yu-Li Veternas Hospital, Hualien, Taiwan

Efficacy Study on Cognitive Functions in Schizophrenic Patients

Phase 4
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2008-09-29
Last Posted Date
2010-12-09
Lead Sponsor
Sanofi
Target Recruit Count
37
Registration Number
NCT00761670
Locations
🇭🇺

Sanofi-Aventis Administrative Office, Budapest, Hungary

Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis

Phase 2
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2008-03-05
Last Posted Date
2008-03-18
Lead Sponsor
University of Cologne
Target Recruit Count
42
Registration Number
NCT00628290
Locations
🇩🇪

University of Cologne, Dept. of Psychiatry and Psychotherapy, Cologne, NRW, Germany

Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors

Phase 1
Completed
Conditions
Obsessive-Compulsive Disorder
First Posted Date
2007-05-10
Last Posted Date
2014-09-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
52
Registration Number
NCT00471588
Locations
🇬🇧

GSK Investigational Site, Cambridge, Cambridgeshire, United Kingdom

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