Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

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.

More Schizophrenia trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorCentre for Addiction and Mental Health
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedOctober 15, 2016
Main results expectedSeptember 30, 2027
Study endsDecember 31, 2027
Registry record updatedAugust 25, 2026
Trial IDNCT02639702 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.