RecruitingPhase 4NCT02639702

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

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


Sponsor

Centre for Addiction and Mental Health

Enrollment

30 participants

Start Date

Aug 1, 2016

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

  • Having significant medical or neurological illnesses
  • Pregnant or lactating

Interventions

DRUGClozapine

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


Locations(1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

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NCT02639702


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