Table of Contents
- Overview of the trials
- Trial 1: Early intensified treatment after first treatment failure
- Trial 2: Maintenance treatment after remission from first episode psychosis
- What the trials measure
- Who the studies are for
- Study design and phases
Overview of the trials
The trial data show two Phase 3 studies that include Sertindole as one of several antipsychotic medicines being studied.[1][2] Both studies are interventional, which means researchers assign treatment strategies and then measure the results.[1][2]
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.[1][2]
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.[1] The study compares a six-week intensified pharmacological treatment with treatment as usual.[1]
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.[1] The trial is authorised, is in Phase 3, and plans to include 418 participants.[1]
The main question is whether early intensified treatment improves symptoms more than usual care over six weeks.[1]
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.[2] It compares continuing antipsychotic medication for at least one year with early dose reduction or discontinuation.[2]
Sertindole is listed among the antipsychotic medicines included in this study, together with haloperidol, clozapine, paliperidone, olanzapine, risperidone, and others.[2] The trial is authorised, is in Phase 3, and plans to enroll 444 participants.[2]
This study focuses on long-term personal and social functioning, not only short-term symptom control.[2]
What the trials measure
The first trial uses the PANSS total score as its primary outcome.[1] PANSS stands for Positive and Negative Syndrome Scale, a standard way to measure symptom severity in psychosis.[1] The study compares the mean change from baseline to six weeks between the two treatment arms.[1]
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.[2] WHODAS-II stands for World Health Organization Disability Assessment Schedule and is used to measure daily functioning and social participation.[2]
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.[1] This makes the study relevant for patients whose first treatment did not work well enough.[1]
The second study is for patients who have recovered enough to be in remission after a first episode of psychosis.[2] This group is being studied because researchers want to know whether staying on medication is better than reducing or stopping it early.[2]
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.[1][2] One study is randomised and controlled, while the other compares continuation with dose reduction or discontinuation in a long-term setting.[1][2]
Together, the studies show that Sertindole is being examined within broader treatment plans for psychosis, rather than as a stand-alone focus.[1][2]
