In short
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.
Key points
- Amisulpride is being studied in Phase 3 clinical trials for both mental health and surgical care. In schizophrenia spectrum disorders, the trials compare different treatment strategies and measure symptom severity, functional remission, and long-term social recovery. In children after surgery, Amisulpride is being tested to prevent post-operative nausea and vomiting. The target groups include people with schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic episode, and pediatric surgical patients. Some studies compare Amisulpride with other antipsychotic medicines or with standard care. The trial results focus on how well the treatment works in real patient groups and what outcomes matter most to daily life.
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. 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.
Trials in schizophrenia spectrum disorders
NCT05958875 is a randomized, controlled trial in people with schizophrenia spectrum disorders, including schizophrenia, schizoaffective disorder, and schizophreniform disorder. It studies a six-week intensified treatment approach after a first-time treatment failure on first-line treatment, compared with treatment as usual. PANSS total score is the main outcome, which means the study is measuring change in symptom severity.
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. The study also plans subgroup analysis, especially for participants who had a first-time treatment failure on their first-line treatment. This means the researchers want to see whether the treatment approach works differently in that specific group.
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. 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. The main outcome is functional remission, measured by a PSP score above 70 at 24 months.
In this study, Amisulpride is one of the antipsychotic medicines listed among the possible treatments in the trial. The researchers want to know whether the effect of dose reduction versus maintenance differs between people with Cycloid Psychosis and those without it. The trial is designed as a personalized medicine approach, meaning treatment is matched to patient features in a more tailored way.
Trial in children after surgery
NCT05546359 is a completed Phase 3 study in pediatric patients with post-operative nausea and vomiting. The trial tested intravenous Amisulpride as a way to prevent nausea and vomiting after surgery. It compared Amisulpride with dexamethasone phosphate and ondansetron, which are other medicines used in this setting.
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. This trial enrolled 410 children, so it gives a fairly large look at how well the treatment may work in this setting.
Outcomes measured in the studies
The studies measure outcomes that matter in everyday life and symptom control. In schizophrenia-related trials, the main outcomes include change in symptom severity, functional remission, and long-term social recovery. In the surgical trial, the main outcome is whether the child has no nausea or vomiting and does not need rescue treatment after surgery.
The PSP score is used to measure personal and social performance, while WHODAS-II is used to measure disability and social functioning. These tools help researchers look beyond symptoms and see how well patients function in daily life.
What participation means
These studies include people with different needs, but all are looking at treatment results in real-world patient groups. Some participants have ongoing schizophrenia spectrum illness, some have recovered after a first psychotic episode, and one group is children recovering from surgery.
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. The trial designs include randomized and controlled methods, which help make the comparison between treatments more reliable.