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)

A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population

Phase 3
Not yet recruiting
Conditions
Post Operative Nausea and Vomiting
Interventions
Drug: Placebo Preventative
Drug: Placebo Treatment
First Posted Date
2024-09-05
Last Posted Date
2024-09-05
Lead Sponsor
Benaroya Research Institute
Target Recruit Count
100
Registration Number
NCT06585540
Locations
🇺🇸

Virginia Mason Medical Center, Seattle, Washington, United States

Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body

Phase 1
Recruiting
Conditions
Bioequivalence
Schizophrenia
First Posted Date
2023-10-04
Last Posted Date
2023-10-04
Lead Sponsor
The Affiliated Hospital of Qingdao University
Target Recruit Count
100
Registration Number
NCT06066112
Locations
🇨🇳

The Affiliated Hospital of Qingdao University Phase I Clinical Research Center, Qingdao, Shandong, China

A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV.

Phase 3
Not yet recruiting
Conditions
PONV
Interventions
First Posted Date
2023-04-21
Last Posted Date
2023-04-21
Lead Sponsor
Qilu Pharmaceutical (Hainan) Co., Ltd.
Target Recruit Count
516
Registration Number
NCT05822713

Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients

Phase 2
Recruiting
Conditions
Nausea and Vomiting, Postoperative
Interventions
First Posted Date
2022-09-19
Last Posted Date
2024-04-25
Lead Sponsor
Acacia Pharma Ltd
Target Recruit Count
410
Registration Number
NCT05546359
Locations
🇫🇷

HCL - Hôpital Mère Enfant, Bron, France

🇩🇪

Universitätsklinikum Würzburg, Würzburg, Bayern, Germany

🇺🇸

UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 11 locations

Effects of a Single Dose of Amisulpride on Functional Brain Changes

Phase 1
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2022-04-26
Last Posted Date
2023-11-24
Lead Sponsor
Simone Grimm
Target Recruit Count
127
Registration Number
NCT05347199
Locations
🇩🇪

Charité Research Organisation GmbH, Berlin, Germany

Post Operative Nausea and Vomiting (PONV) Rescue Outcomes After Amisulpride Treatment

Withdrawn
Conditions
Nausea and Vomiting, Postoperative
Interventions
Drug: Rescue Post-Operative Nausea and Vomiting (PONV) treatment according to the standard of care (SOC)
First Posted Date
2021-07-08
Last Posted Date
2023-04-07
Lead Sponsor
Acacia Pharma Ltd
Registration Number
NCT04954365

Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression

Phase 4
Conditions
Post-Schizophrenic Depression
Interventions
Drug: Olanzapine-Fluoxetine Combination
First Posted Date
2021-05-06
Last Posted Date
2021-06-03
Lead Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Target Recruit Count
60
Registration Number
NCT04876521
Locations
🇮🇳

All India Institute of Medical Sciences, Bhubaneswar, Orissa, India

PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment

Phase 1
Completed
Conditions
Renal Disease, End Stage
Interventions
First Posted Date
2021-04-19
Last Posted Date
2021-12-13
Lead Sponsor
Acacia Pharma Ltd
Target Recruit Count
12
Registration Number
NCT04849650
Locations
🇺🇸

Panax Clinical Research, Miami Lakes, Florida, United States

Psychobiological Mechanisms Underlying Chronic Pain

Not Applicable
Completed
Conditions
Pain, Chronic
Fibromyalgia
Chronic Pain, Widespread
Interventions
First Posted Date
2020-12-19
Last Posted Date
2023-09-07
Lead Sponsor
susanne becker
Target Recruit Count
48
Registration Number
NCT04674670
Locations
🇨🇭

Balgrist Campus, Zürich, Switzerland

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