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Amisulpride

Clinical trials investigating Amisulpride are studying how it performs in different patient groups, including people with schizophrenia spectrum disorders and children after surgery. These studies look at treatment response, functional recovery, and prevention of nausea and vomiting. They also compare Amisulpride with other treatment strategies or medicines.

Table of contents

Clinical trials overview

The trial data show four interventional studies of Amisulpride, all in Phase 3 and with a total focus on real patient outcomes.[1][2][3][4] Two studies are in people with schizophrenia spectrum disorders, one is in children after surgery, and one looks at people who have recovered after a first episode of psychosis.[1][2][3][4]

Trials in schizophrenia spectrum disorders

NCT05958875 is a randomized, controlled trial in people with schizophrenia spectrum disorders, including schizophrenia, schizoaffective disorder, and schizophreniform disorder.[1] It studies a six-week intensified treatment approach after a first-time treatment failure on first-line treatment, compared with treatment as usual.[1] PANSS total score is the main outcome, which means the study is measuring change in symptom severity.[1]

In this study, Amisulpride is one of many antipsychotic medicines that may be used in the treatment arms, alongside other medicines such as quetiapine, paliperidone, clozapine, risperidone, and others.[1] The study also plans subgroup analysis, especially for participants who had a first-time treatment failure on their first-line treatment.[1] This means the researchers want to see whether the treatment approach works differently in that specific group.[1]

2023-509558-80-00 is another Phase 3 randomized and controlled study in patients with schizophrenia spectrum disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, or brief psychotic episode according to DSM-5.[2] This trial compares Dose Reduction versus Maintenance Treatment after stratification based on psychotic phenotype, which means the patients are grouped by certain symptom patterns before comparison.[2] The main outcome is functional remission, measured by a PSP score above 70 at 24 months.[2]

In this study, Amisulpride is one of the antipsychotic medicines listed among the possible treatments in the trial.[2] The researchers want to know whether the effect of dose reduction versus maintenance differs between people with Cycloid Psychosis and those without it.[2] The trial is designed as a personalized medicine approach, meaning treatment is matched to patient features in a more tailored way.[2]

Trial in children after surgery

NCT05546359 is a completed Phase 3 study in pediatric patients with post-operative nausea and vomiting.[3] The trial tested intravenous Amisulpride as a way to prevent nausea and vomiting after surgery.[3] It compared Amisulpride with dexamethasone phosphate and ondansetron, which are other medicines used in this setting.[3]

The main outcome was Complete Response, defined as no vomiting or retching and no use of rescue anti-emetic medicine during the first 24 hours after surgery.[3] This trial enrolled 410 children, so it gives a fairly large look at how well the treatment may work in this setting.[3]

Outcomes measured in the studies

The studies measure outcomes that matter in everyday life and symptom control.[1][2][3][4] In schizophrenia-related trials, the main outcomes include change in symptom severity, functional remission, and long-term social recovery.[1][2][4] In the surgical trial, the main outcome is whether the child has no nausea or vomiting and does not need rescue treatment after surgery.[3]

The PSP score is used to measure personal and social performance, while WHODAS-II is used to measure disability and social functioning.[2][4] These tools help researchers look beyond symptoms and see how well patients function in daily life.[2][4]

What participation means

These studies include people with different needs, but all are looking at treatment results in real-world patient groups.[1][2][3][4] Some participants have ongoing schizophrenia spectrum illness, some have recovered after a first psychotic episode, and one group is children recovering from surgery.[1][2][3][4]

Because these are Phase 3 studies, the main goal is to learn how well the treatment strategies work in larger groups and how they compare with other options.[1][2][3][4] The trial designs include randomized and controlled methods, which help make the comparison between treatments more reliable.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT05958875 Phase 3 Schizophrenia, schizoaffective disorder, schizophreniform disorder Authorised 418
2023-509558-80-00 Phase 3 Schizophrenia spectrum disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic episode Authorised 288
NCT05546359 Phase 3 Post-operative nausea and vomiting in pediatric patients Completed 410
2024-518769-80-00 Phase 3 Patients remitted after a first episode of psychosis Authorised 444

FAQ

  • What are the Amisulpride clinical trials studying? The trials are studying different uses of Amisulpride, including treatment strategies for schizophrenia spectrum disorders and prevention of post-operative nausea and vomiting in children. They focus on outcomes such as symptom improvement, functional recovery, and complete response after surgery.
  • Who can take part in these trials? Some trials include people with schizophrenia, schizoaffective disorder, schizophreniform disorder, or brief psychotic episode. One trial includes pediatric patients after surgery.
  • What phases are the Amisulpride trials in? The trials listed are mainly Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to see how well it works and how it compares with other options.
  • What outcomes are being measured? The studies measure different outcomes depending on the trial. These include PANSS total score for symptom severity, PSP score for functional remission, WHODAS-II for social recovery, and complete response for prevention of nausea and vomiting.
  • Is Amisulpride being tested alone in all trials? No. In some studies, Amisulpride is one of several treatment options used in a comparison of antipsychotic medicines. In the surgical study, it is tested as a preventive treatment against nausea and vomiting.

Ongoing Clinical Trials on Amisulpride

  • Study on the Effect of Clozapine and Drug Combination for Patients with Schizophrenia Experiencing First-Line Treatment Failure

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Italy Spain

  • Study on Reducing Antipsychotic Dose vs. Maintenance Treatment for Patients with Schizophrenia Using Haloperidol Decanoate, Risperidone, and Amisulpride

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study on Amisulpride, Dexamethasone Phosphate, and Ondansetron for Preventing Post-Operative Nausea and Vomiting in Children

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France Germany

  • Study on Continuing or Reducing Antipsychotic Medication (Haloperidol, Clozapine, Tiapride) for Patients After First Episode of Psychosis

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Schizophrenia spectrum disorder: A group of mental health conditions that can affect thoughts, feelings, and behavior. In these trials, it includes schizophrenia, schizoaffective disorder, schizophreniform disorder, and brief psychotic episode.
  • Phase 3: A late stage of a clinical trial where a treatment is tested in larger groups of people to see how well it works and how it compares with other treatments.
  • Interventional study: A trial where researchers assign a treatment or strategy to participants and then measure the results.
  • PANSS: Short for Positive and Negative Syndrome Scale. It is a score used to measure symptom severity in schizophrenia-related conditions.
  • Functional remission: A state where a person has a good level of everyday functioning, not just fewer symptoms.
  • PSP: Short for Personal and Social Performance Scale. It measures how well a person manages daily life, work, and social activities.
  • WHODAS-II: A questionnaire that measures disability and how a health condition affects daily life and social functioning.
  • Complete response: In the surgery trial, this means no vomiting or retching and no need for rescue anti-nausea medicine during the first 24 hours after surgery.
  • Post-operative nausea and vomiting: Nausea and vomiting that happen after surgery.
  • Treatment as usual: The standard care or regular treatment approach used in practice.

References