CLEAR
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
Find out more by filling in this form
Conditions
SchizophreniaInclusion 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
i. Psychosis predominantly caused by substance misuse
ii. Pregnancy
iii. Breastfeeding
iv. Contra-indications to clozapine as listed in SmPC as follows:
a. Hypersensitivity to the active substance or to any of the excipients,listed in section 6.1.
b. Patients unable to undergo regular blood tests.
c. History of toxic or idiosyncratic granulocytopenia/agranulocytosis (with the exception of granulocytopenia/agranulocytosis from previous chemotherapy).
d. History of clozapine-induced agranulocytosis.
e. Impaired bone marrow function.
f. Uncontrolled epilepsy.
g. Alcoholic and other toxic psychoses,drug intoxication,comatose conditions.
h. Circulatory collapse and/or CNS depression of any cause.
i. Severe renal or cardiac disorders (e.g. myocarditis).
j. Active liver disease associated with nausea,anorexia or jaundice; progressive liver disease,hepatic failure.
k. Paralytic ileus.
l. 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.
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.
