Table of Contents
- Trial overview
- Trial 1: Symptom response in schizophrenia
- Trial 2: Long-term recovery after first episode of psychosis
- Who the trials include
- What the trials measure
- What Phase 3 means
Trial overview
These studies are testing Lurasidone in real clinical research settings for people with psychosis-related conditions.[1][2] Both trials are interventional studies, which means researchers assign treatment plans and then measure the results.[1][2] Both are in Phase 3 and are listed as authorised.[1][2]
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.[1] A randomised trial means people are assigned by chance to different treatment groups.[1] The study compares a six-week intensified pharmacological treatment with treatment as usual.[1]
Intensified pharmacological treatment means a stronger or more active medicine plan than usual care.[1] In this trial, Lurasidone is one of many antipsychotic medicines that may be used in the treatment strategy.[1] The primary outcome is the change in symptom severity measured by the PANSS total score after six weeks.[1]
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.[1]
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.[2] 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.[2] Lurasidone is listed among the antipsychotic medicines included in the study.[2]
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.[2] The primary outcome is based on what patients and their relatives considered most important and is measured with the WHODAS-II tool.[2] This makes the study especially focused on daily life and social recovery, not only on symptoms.[2]
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.[1] The second trial includes patients who have remitted after a first episode of psychosis.[2] In simple terms, remission means the symptoms have improved a lot or are mostly under control.[2]
- People with ongoing psychotic illness: These participants are being studied to see whether a stronger treatment plan can reduce symptoms more than usual care.[1]
- 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.[2]
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.[1] Baseline means the starting point before the treatment effect is measured.[1] 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.[1]
The main measure in the HAMLETT study is long-term social recovery, assessed with WHODAS-II.[2] This is important because it helps show how well patients manage everyday life, not just whether symptoms improve.[2]
What Phase 3 means
Both studies are in Phase 3, which is a later stage of testing before a treatment is more widely used.[1][2] Phase 3 studies usually include larger groups of patients and compare treatment approaches to learn which one works better in practice.[1][2] In these trials, the focus is on treatment response, symptom control, and long-term functioning.[1][2]
