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

Schizophrenia | Schizoaffective Disorder

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Gary Remington, MD, PhD

[email protected]
416-535-8501
Study Sponsored By
Centre for Addiction and Mental Health
Participants Required
More Information
Study ID: NCT02639702