Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre for Addiction and Mental Health
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.