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

Recruiting now · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT02639702

Run by

Centre for Addiction and Mental Health

People needed

30

Starts

2016-08-01

Expected to finish

2026-12-01

Last updated by the study team

2023-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Having significant medical or neurological illnesses
• Pregnant or lactating

Where it is running

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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