Switching clozapine dosing from twice daily to once daily for schizophrenia
Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia: A Pilot, Double-Blind, Randomized Controlled Trial
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 |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT02639702 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with significant medical or neurological illnesses, or those who are pregnant or lactating, may not benefit from this study.
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 performed: Previous studies have shown that once-daily dosing of other antipsychotics is effective, suggesting potential for success in this novel approach with clozapine.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.