NCT02639702RecruitingPhase 4
Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia
Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia: A Pilot, Double-Blind, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Dec 2015
- Start date
- 15 Oct 2016
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Schizophrenia
- NCT number
- NCT02639702
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 15 Oct 2016 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having significant medical or neurological illnesses
Other
- Pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.