In short
Clinical trials are studying Lurasidone in people with schizophrenia and in patients who have recovered after a first episode of psychosis. These studies look at whether treatment plans that include Lurasidone can improve symptoms, support recovery, and measure long-term functioning and safety in real trial settings.
Key points
- Clinical trials are studying Lurasidone in people with psychosis-related conditions, especially schizophrenia and recovery after a first episode of psychosis. Both trials are Phase 3 studies, which means they compare treatment approaches in larger groups of patients. One trial measures symptom change with the PANSS score over six weeks. The other looks at long-term social recovery and daily functioning with WHODAS-II. The trial data show Lurasidone being used among several antipsychotic medicines in broader treatment strategies.
Trial overview
These studies are testing Lurasidone in real clinical research settings for people with psychosis-related conditions. Both trials are interventional studies, which means researchers assign treatment plans and then measure the results. Both are in Phase 3 and are listed as authorised.
Trial 1: Symptom response in schizophrenia
NCT05958875 is a randomised, controlled trial in people with schizophrenia, schizoaffective disorder, or schizophreniform disorder who had a first-time treatment failure on first-line treatment. A randomised trial means people are assigned by chance to different treatment groups. The study compares a six-week intensified pharmacological treatment with treatment as usual.
Intensified pharmacological treatment means a stronger or more active medicine plan than usual care. In this trial, Lurasidone is one of many antipsychotic medicines that may be used in the treatment strategy. The primary outcome is the change in symptom severity measured by the PANSS total score after six weeks.
This trial also plans subgroup analysis, which means the results may be looked at separately for certain groups, including people who had first-time treatment failure and the full study group.
Trial 2: Long-term recovery after first episode of psychosis
2024-518769-80-00 is the HAMLETT study, which stands for Handling Antipsychotic Medication: Long-term Evaluation of Targeted Treatment. It compares continuing antipsychotic medication for at least one year with early dose reduction or discontinuation in patients who are in remission after a first episode of psychosis. Lurasidone is listed among the antipsychotic medicines included in the study.
The study looks at personal and social functioning over both short-term and long-term periods, including 1 to 2 years and 3 to 4 years. The primary outcome is based on what patients and their relatives considered most important and is measured with the WHODAS-II tool. This makes the study especially focused on daily life and social recovery, not only on symptoms.
Who the trials include
The first trial includes people with schizophrenia, schizoaffective disorder, or schizophreniform disorder, especially those who had a first treatment failure on first-line treatment. The second trial includes patients who have remitted after a first episode of psychosis. In simple terms, remission means the symptoms have improved a lot or are mostly under control.
- People with ongoing psychotic illness: These participants are being studied to see whether a stronger treatment plan can reduce symptoms more than usual care.
- People in remission after first psychosis: These participants are being studied to see whether continuing, reducing, or stopping medication affects long-term recovery and daily function.
What the trials measure
The main measure in NCT05958875 is the change in symptom severity from baseline to week six using the PANSS total score. Baseline means the starting point before the treatment effect is measured. A lower PANSS score usually means fewer or less severe symptoms, but the trial data only state that the score will be compared between groups.
The main measure in the HAMLETT study is long-term social recovery, assessed with WHODAS-II. This is important because it helps show how well patients manage everyday life, not just whether symptoms improve.
What Phase 3 means
Both studies are in Phase 3, which is a later stage of testing before a treatment is more widely used. Phase 3 studies usually include larger groups of patients and compare treatment approaches to learn which one works better in practice. In these trials, the focus is on treatment response, symptom control, and long-term functioning.