Clozapine in early psychosis (CLEAR): A multi-centre, randomised controlled trial of clozapine for young people with treatment resistant psychosis in real world settings
Overview
What is CLEAR?
CLEAR is a new clinical trial investigating if a medication called clozapine can help improve symptoms of psychosis in young people.
Who can take part?
We are looking for young people 12-25 years old with psychosis, who have already tried more than two different antipsychotic medication and did not find them very helpful, to help treat their psychotic symptoms.
What’s involved?
A computer will randomly decide whether you are prescribed clozapine or another antipsychotic for 12 weeks A researcher will meet you 4 times during this time to ask you questions about how you’re feeling and if you’re experiencing any side effects.
Compensation
You will be reimbursed for your participation.
Planned end date
28 Feb 2027 23:59Conditions
Psychosis,SchizophreniaPeople types
Adolescent 13 - 17,Adult 18+Inclusion Criteria
i. Age ≥12 and <-25 years at randomisation.
ii. Meets criteria for schizophrenia or related disorder,in the range in the range ICD-10v2016 F20.x,F22.x-F29.x
iii. Meets NICE criteria for treatment resistance,defined as:
a. Previous trials of at least two different antipsychotic drugs with adequate adherence (estimated <20% missed doses) – both treatment trials to exceed 6 weeks at therapeutic dose (≥600 mg chlorpromazine equivalent).
b. At least 1 of these trials must be with a second-generation drug
c. Failure to respond to NICE-recommended psychological treatment OR failure to engage in same
d. Positive and Negative Syndrome Scale (PANSS) total ≥70,at least 2 items >4
e. Compliance Rating Scale [23] (CRS) >3
iv. English or Welsh language sufficient to participate
v. Capacity to give informed consent OR has a consultee (normally a family member) able to give consent to the trial.
Exclusion Criteria
have a substantial potential for causing agranulocytosis; concomitant use of depot antipsychotics is to be discouraged.
v. Previous adequate trial of clozapine
vi. CNS disorders (ICD-10 G00-26; G40-41,G45-46; G80-94,G97)
vii. Concurrent medications with documented interactions with antipsychotics
viii. Participation in a medicinal trial involving an unlicensed,investigational medical product within the last 3 months
ix. Positive test for COVID-19 within the past 10 days.