Actively Recruiting
Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia
Led by Centre for Addiction and Mental Health · Updated on 2023-09-07
30
Participants Needed
1
Research Sites
539 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. However, to date, several randomized controlled trials (RCTs) have shown no differences in clinical outcomes between once- and twice-daily dosing of various antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life. This would apply to clozapine as well; however, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. To address this gap in the literature, the investigators shall conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.
CONDITIONS
Official Title
Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with schizophrenia or schizoaffective disorder based on DSM-IV criteria
- Outpatient status
- Ages 18 years or older
- Receiving clozapine twice daily, with one dose in the evening or at bedtime, at the same dose and schedule for at least 3 months
- Fluent in English and able to provide written informed consent
You will not qualify if you...
- Having significant medical or neurological illnesses
- Pregnant or lactating
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Actively Recruiting
Research Team
G
Gary Remington, MD, PhD
CONTACT
C
Carol Borlido, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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