Once-Daily vs Twice-Daily Clozapine for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you have been taking clozapine twice a day for at least 3 months. It seems you will continue with clozapine, but the dosing schedule might change.
Is once-daily clozapine dosing safe compared to twice-daily dosing?
How does once-daily clozapine dosing differ from other schizophrenia treatments?
Once-daily clozapine dosing is unique because it simplifies the medication regimen, potentially improving adherence, despite the drug's short half-life which typically suggests twice-daily dosing. This approach is often used to manage side effects like sedation by administering the dose at bedtime.23467
What data supports the effectiveness of once-daily versus twice-daily clozapine dosing for schizophrenia?
Who Is on the Research Team?
Gary Remington, MD, PhD
Principal Investigator
Centre for Addiction and Mental Health
Are You a Good Fit for This Trial?
This trial is for adults over 18 with schizophrenia or schizoaffective disorder, currently taking clozapine twice daily. They must be outpatients, fluent in English, and able to consent. It's not for those with serious medical conditions or women who are pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are switched from twice-daily to once-daily clozapine dosing or continue with twice-daily dosing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Switching From Twice-Daily to Once-Daily Clozapine Dosing
Switching From Twice-Daily to Once-Daily Clozapine Dosing is already approved in United States, European Union, Canada for the following indications:
- Schizophrenia
- Recurrent suicidal behavior in people with schizophrenia or schizoaffective disorder
- Schizophrenia
- Recurrent suicidal behavior in people with schizophrenia or schizoaffective disorder
- Schizophrenia
- Recurrent suicidal behavior in people with schizophrenia or schizoaffective disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor