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Contact Information:

Prof James MacCabe
+44 207 848 0757
james.maccabe@kcl.ac.uk


Prof Alice Egerton
-
Alice.Egerton@kcl.ac.uk


Dr Study Team
+44 20 71885732
clear@kcl.ac.uk


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Be Part of Research - Trial Details - Investigating the use of clozapine in young people with psychosis
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Investigating the use of clozapine in young people with psychosis

Recruiting

Open to: All Genders

Age: Mixed

London Beckenham Exeter Oxford Manchester Wakefield

Medical Conditions

Treatment resistant psychosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

31 Jan 2023 31 Aug 2026

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.

Some participants in the clinical trial will additionally be asked to complete a magnetic resonance imaging (MRI) brain scan and provide a blood sample, once at the beginning and once at the end of the twelve-week period. The MRI scans will be used to measure glutamate and related aspects of brain structure and function. The blood samples will be used to measure proteins in the blood involved in inflammation, such as cytokines. At the end of the study, we will see if the biological measures in the brain and blood change more during treatment with clozapine compared to other antipsychotics, and how they relate to the amount that symptoms improve.


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.

You can take part if:



You may not be able to take part if:


1. Psychosis predominantly caused by substance misuse2. Pregnancy 3. Breastfeeding4. Contra-indications to clozapine as listed in BNF SmPC as follows:4.1. Hypersensitivity to the active substance or to any of the excipients4.2. Patients unable to undergo regular blood tests.4.3. History of toxic or idiosyncratic granulocytopenia/agranulocytosis (with the exception of granulocytopenia/agranulocytosis from previous chemotherapy).4.4. History of clozapine-induced agranulocytosis.4.5. Impaired bone marrow function.4.6. Uncontrolled epilepsy.4.7. Alcoholic and other toxic psychoses, drug intoxication, comatose conditions.4.8. Circulatory collapse and/or CNS depression of any cause.4.9. Severe renal or cardiac disorders (e.g. myocarditis).4.10. Active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure.4.11. Paralytic ileus.4.12. Clozapine treatment must not be started concurrently with substances known to have a substantial potential for causing agranulocytosis; concomitant use of depot antipsychotics is to be discouraged.5. Previous adequate trial of clozapine6. CNS disorders (ICD-10 G00-26; G40-41, G45-46; G80-94, G97).7. Concurrent medications with documented interactions with antipsychotics8. Participation in a medicinal trial involving an unlicensed, investigational medical product within the last 3 months9. Positive test for COVID-19 within the past 10 days.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Maudsley Hospital
    Denmark Hill
    London
    SE5 8AZ
  • Bethlem Royal Hospital
    Monks Orchard Road
    Beckenham
    BR3 3BX
  • Wonford House
    Wonford House Hospital Dryden Road
    Exeter
    EX2 5AF
  • Warneford Hospital
    Warneford Lane Headington
    Oxford
    OX3 7JX
  • Royal Manchester Childrens Hospital
    Hospital Road Pendlebury Swinton
    Manchester
    M27 4HA
  • Fieldhead Hospital
    Ouchthorpe Lane
    Wakefield
    WF1 3SP

Benefits:
Not provided at time of registration
Risks:
People with schizophrenia are routinely treated with antipsychotic medication as part of their usual care, and the participants will also be treated with antipsychotic - it is only the choice of antipsychotic that will be determined by the trial. The potential risks and burdens for research participants will thus be the same as standard care. To minimise side effects, clinicians will have complete freedom to adjust the dose to achieve the best balance between therapeutic and adverse effects. Treatment to combat side effects can also be given to participants in the same way as with usual care. Advice to prevent common side effects such as weight gain and sedation will be given at the beginning of the trial. Participants might not respond to treatment. Nonetheless, after the first 12 weeks of trial, treatment can be changed while remaining in the study for longer-term outcome.

Prof Alice Egerton
-
Alice.Egerton@kcl.ac.uk


Prof James MacCabe
+44 207 848 0757
james.maccabe@kcl.ac.uk


Dr Study Team
+44 20 71885732
clear@kcl.ac.uk



The study is sponsored by King's College London; South London and Maudsley NHS Foundation Trust and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN37176025

Or CPMS 53859

Last updated 01 February 2023

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