Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia: A Pilot, Double-Blind, Randomized Controlled Trial

Who is this study for? Adult patients with schizophrenia
What treatments are being studied? Clozapine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Centre for Addiction and Mental Health
RECRUITING
Toronto
Contact Information
Primary
Gary Remington, MD, PhD
Gary.Remington@camh.ca
+1-416-535-8501
Backup
Carol Borlido, BSc
carol.borlido@camh.ca
416 535-8501
Time Frame
Start Date: 2016-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: Switch group
Participants will receive clozapine once daily at evening or bedtime throughout the study period. If a participant takes ≥200 mg of clozapine at a time other than evening/bedtime, half of this dose will be switched to an evening/bedtime regimen on day 0 (baseline), then another half dose will be switched on day 7 (week 1). Participants will receive placebo in place of the clozapine dose that was switched to evening/bedtime.
No_intervention: Maintenance group
Participants will continue to take clozapine twice daily throughout the study period.
Related Therapeutic Areas
Sponsors
Leads: Centre for Addiction and Mental Health

This content was sourced from clinicaltrials.gov