Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia
Recruiting · NCT02639702 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre for Addiction and Mental Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
1 location listed.
- Centre for Addiction and Mental Health - Toronto, Ontario, Canada