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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - Having significant medical or neurological illnesses - Pregnant or lactating Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Clozapine

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

Locations (1)

Centre for Addiction and Mental Health
Toronto, Ontario, Canada