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Once-Daily vs Twice-Daily Clozapine for Schizophrenia
Phase 4
Recruiting
Led By Gary Remington, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18 years or older
Has received clozapine twice a day, one of which is in the evening/bedtime, at the same dose and dosing regimen for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 and 12 weeks
Awards & highlights
Study Summary
This trial will compare the effects of taking clozapine once a day versus taking it twice a day.
Who is the study for?
This trial is for adults over 18 with schizophrenia or schizoaffective disorder, currently taking clozapine twice daily. They must be outpatients, fluent in English, and able to consent. It's not for those with serious medical conditions or women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests if taking clozapine once a day is as effective and tolerable as the standard twice-daily dose for schizophrenia treatment. Participants will be randomly assigned to one of the dosing schedules in a controlled environment.See study design
What are the potential side effects?
Clozapine can cause side effects like drowsiness, dizziness, rapid heartbeat, constipation, excessive salivation, and in rare cases may affect white blood cell count leading to infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been taking clozapine twice daily, including bedtime, at the same dose for 3 months.
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.
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I am not currently admitted to a hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Psychiatric Rating 18 item Scale (BPRS 18 item scale)
Secondary outcome measures
Brief Evaluation of Psychosis Symptom Domains (BE-PSD)
Brief Neurocognitive Assessment (BNA)
Fetal Distress
+4 moreSide effects data
From 2008 Phase 4 trial • 25 Patients • NCT0000165631%
Increased appetite
31%
Hypersalivation
17%
tachycardia >100 beats/min (supine)
15%
Somnolence
15%
Constipation
9%
Hypertension
8%
Difficulty concentrating
8%
Insomnia
8%
Enuresis
8%
Abnormal white blood count
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olanzapine Group
Clozapine Group
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Switch groupExperimental Treatment1 Intervention
Participants will receive clozapine once daily at evening or bedtime throughout the study period. If a participant takes ≥200 mg of clozapine at a time other than evening/bedtime, half of this dose will be switched to an evening/bedtime regimen on day 0 (baseline), then another half dose will be switched on day 7 (week 1). Participants will receive placebo in place of the clozapine dose that was switched to evening/bedtime.
Group II: Maintenance groupActive Control1 Intervention
Participants will continue to take clozapine twice daily throughout the study period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clozapine
2000
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,414 Total Patients Enrolled
Gary Remington, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
2 Previous Clinical Trials
58 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Centre for Addiction and Mental Health
What portion of applicants met pre-screening criteria?
Met criteria
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