Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia

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.

NCT Number	NCT02639702
Lead Sponsor	Centre for Addiction and Mental Health
Conditions	Schizophrenia, Schizoaffective Disorder
Enrollment	30 participants
Start Date	2016-08
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2023-09-07