CLEAR: CLozapine in EARly psychosis
Research type
Research Study
Full title
CLEAR: (CLozapine in EARly psychosis) A Multi-Centre, Randomised Controlled trial of Clozapine for Young People with Treatment Resistant Psychosis in Real World Settings
IRAS ID
1004947
Contact name
James MacCabe
Contact email
Eudract number
2021-006248-28
ISRCTN Number
ISRCTN37176025
Research summary
Schizophrenia is a condition that causes symptoms like delusions, hallucinations, reduced motivation and muddled thinking. Schizophrenia usually starts in the twenties but can begin earlier, when it is often more severe. The main treatment is antipsychotic medication; if untreated, symptoms typically continue for many years. One antipsychotic, clozapine, works better than any other and has the best chance of working if started early on in treatment. On the other hand, clozapine has more side effects than some other antipsychotics, so doctors only use it when other drugs haven't helped. For this reason, almost all research on clozapine was done with adults who had already taken other antipsychotics. Research in children and young people with schizophrenia shows that antipsychotics do help them, but there is little research focussed on clozapine. Three studies suggest that clozapine works better than other antipsychotics in children and young people, but the studies were too small to be conclusive and doctors still don’t use it often, leading to enduring symptoms. Therefore we will study clozapine as a treatment for schizophrenia in young people, recruiting only people <25 years old and trying to recruit as many as possible aged <18. We will include 260 people, recruited across various hospital clinics and services within the UK, who are still symptomatic after treatment with at least two antipsychotics. A computer will decide randomly whether each person will take clozapine or any other antipsychotic for 12 weeks. Researchers will assess their symptoms several times without knowing which drug they are taking to avoid biases. At the end of the study, towards the end of 2026, we will see if clozapine reduced people’s symptoms more than other antipsychotics, their side effects, how well they feel, how much their treatment costs and how often they need hospital treatment. After the study is over, we will contact them again to see how they are doing in the longer term.
REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0723
Date of REC Opinion
13 Dec 2022
REC opinion
Further Information Favourable Opinion