Switching clozapine dosing from twice daily to once daily for schizophrenia
Official title: Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia: A Pilot, Double-Blind, Randomized Controlled Trial
Run by Centre for Addiction and Mental Health · NCT02639702 · Data updated 2026-11-12
This study is testing if switching people with schizophrenia from taking clozapine twice a day to once a day can still be effective and easier for them to manage.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | October 15, 2016 |
| Main results expected | September 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT02639702 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with schizophrenia or schizoaffective disorder who have been stable on a twice-daily clozapine regimen for at least three months.
✕Probably not a fit
Patients with significant medical or neurological illnesses, or those who are pregnant or lactating, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the efficacy and tolerability of switching patients with schizophrenia from a twice-daily to a once-daily dosing regimen of clozapine. The study will be a pilot, double-blind, randomized controlled trial involving patients who have been on a stable twice-daily clozapine regimen for at least three months. By comparing the outcomes of the two dosing schedules, the trial seeks to determine if once-daily dosing is a viable alternative without compromising treatment effectiveness. The findings could provide insights into optimizing clozapine administration for better patient adherence and comfort.
Why it matters
Potential benefit: If successful, this study could lead to a more convenient dosing schedule for patients, potentially improving adherence and quality of life.
How similar studies have gone: Previous studies have shown that once-daily dosing of other antipsychotics is effective, suggesting potential for success in this novel approach with clozapine.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with schizophrenia or schizoaffective disorder based on DSM-IV criteria * Outpatient status * 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 * Fluent in English and competent to provide written informed consent Exclusion Criteria: * Having significant medical or neurological illnesses * Pregnant or lactating
Where it's running
-
Centre for Addiction and Mental Health
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Gary Remington, MD, PhD — Centre for Addiction and Mental Health
- Study coordinator: Gary Remington, MD, PhD
- Email: Gary.Remington@camh.ca
- Phone: +1-416-535-8501
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.