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

Schizophrenia Schizoaffective Disorder

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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether patients with schizophrenia or related conditions who take clozapine (an antipsychotic medication) can safely switch from taking it twice a day to taking the full dose just once a day at bedtime, which could be more convenient and improve sleep. **You may be eligible if...** - You have been diagnosed with schizophrenia or a related condition - You are currently taking clozapine twice daily and your condition has been stable for at least 3 months - You are an adult (18 years or older) - Your doctor agrees that switching to once-daily dosing is medically appropriate for you **You may NOT be eligible if...** - Your condition is currently unstable or you have had a recent psychiatric crisis - You have a medical condition that makes once-daily dosing unsafe (e.g., certain heart conditions or seizure disorders) - You are unable to provide informed consent - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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