NCT02639702 Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia
| NCT ID | NCT02639702 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2016-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2016-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Gary Remington, MD, PhD
PRINCIPAL INVESTIGATOR
Centre for Addiction and Mental Health
Frequently Asked Questions
Who can join the NCT02639702 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02639702 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02639702 currently recruiting?
Yes, NCT02639702 is actively recruiting participants. Contact the research team at Gary.Remington@camh.ca for enrollment information.
Where is the NCT02639702 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT02639702 clinical trial?
NCT02639702 is sponsored by Centre for Addiction and Mental Health. The principal investigator is Gary Remington, MD, PhD at Centre for Addiction and Mental Health. The trial plans to enroll 30 participants.
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