In short
Clinical trials are investigating Sertindole as part of studies in psychosis-related conditions, including schizophrenia and first-episode psychosis. These trials look at how well treatment works, how symptoms change over time, and how long-term functioning is affected in different patient groups.
Key points
- Clinical trials investigating Sertindole are focused on psychosis-related conditions, especially schizophrenia and recovery after a first episode of psychosis. Both listed studies are Phase 3 and are authorised. One trial compares an early intensified treatment approach with usual care in people who had a first treatment failure, while the other compares continuing antipsychotic treatment with dose reduction or stopping it after remission. The main outcomes include symptom severity measured by PANSS and long-term social recovery measured by WHODAS-II. Sertindole appears as one of several antipsychotic medicines included in these trial treatment groups.
Overview of the trials
The trial data show two Phase 3 studies that include Sertindole as one of several antipsychotic medicines being studied. Both studies are interventional, which means researchers assign treatment strategies and then measure the results.
These trials are not simple drug-only studies. They compare treatment approaches in people with psychosis-related conditions, such as schizophrenia or remission after a first episode of psychosis.
Trial 1: Early intensified treatment after first treatment failure
NCT05958875 is a randomised, controlled trial in people with schizophrenia, schizoaffective disorder, or schizophreniform disorder who had a first-time treatment failure on their first-line treatment. The study compares a six-week intensified pharmacological treatment with treatment as usual.
Sertindole is one of the medicines listed in the intensified treatment options, along with several other antipsychotic medicines such as quetiapine, risperidone, olanzapine, clozapine, and others. The trial is authorised, is in Phase 3, and plans to include 418 participants.
The main question is whether early intensified treatment improves symptoms more than usual care over six weeks.
Trial 2: Maintenance treatment after remission from first episode psychosis
The second study, HAMLETT, looks at people who are in remission after a first episode of psychosis. It compares continuing antipsychotic medication for at least one year with early dose reduction or discontinuation.
Sertindole is listed among the antipsychotic medicines included in this study, together with haloperidol, clozapine, paliperidone, olanzapine, risperidone, and others. The trial is authorised, is in Phase 3, and plans to enroll 444 participants.
This study focuses on long-term personal and social functioning, not only short-term symptom control.
What the trials measure
The first trial uses the PANSS total score as its primary outcome. PANSS stands for Positive and Negative Syndrome Scale, a standard way to measure symptom severity in psychosis. The study compares the mean change from baseline to six weeks between the two treatment arms.
The second trial uses a long-term social recovery measure based on what patients and relatives said matters most, and this is quantified with the WHODAS-II tool. WHODAS-II stands for World Health Organization Disability Assessment Schedule and is used to measure daily functioning and social participation.
Who the studies are for
The first study is for people with schizophrenia, schizoaffective disorder, or schizophreniform disorder who had a first treatment failure on their first-line therapy. This makes the study relevant for patients whose first treatment did not work well enough.
The second study is for patients who have recovered enough to be in remission after a first episode of psychosis. This group is being studied because researchers want to know whether staying on medication is better than reducing or stopping it early.
Study design and phases
Both trials are interventional and Phase 3, which means they are testing treatment strategies in larger groups and looking at real clinical outcomes. One study is randomised and controlled, while the other compares continuation with dose reduction or discontinuation in a long-term setting.
Together, the studies show that Sertindole is being examined within broader treatment plans for psychosis, rather than as a stand-alone focus.