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RECRUITING
NCT02639702
PHASE4

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

Sponsor: Centre for Addiction and Mental Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2016-08

Completion Date

2026-12

Last Updated

2023-09-07

Healthy Volunteers

No

Interventions

DRUG

Clozapine

Switching from twice-daily to once-daily clozapine dosing regimen

Locations (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada