Study of the Effect of Dosing on Clozapine Levels

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this 15-day study are:

1. To compare steady-state trough plasma concentrations of clozapine and its metabolite norclozapine when given once daily and twice daily (at the same total daily dose)

2. To determine if frequency of clozapine administration has an effect on:

1. Symptoms of schizophrenia

2. Adverse effects of clozapine

3. Fasting blood glucose, lipids, creatinine, and urea

4. Weight and waist circumference

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Clozapine

Criteria

Inclusion Criteria:

• Participants must be between the ages of 19 - 65

• Participants must be fluent in English

• Participants must have a psychiatric diagnosis and are currently treated with clozapine once daily in the evening

• Participants must be on a stable dose of clozapine for at least one week to ensure steady-state has been achieved

Exclusion Criteria:

• Participants who are hypersensitive to clozapine

• Participants who are pregnant or lactating

• Participants who are of childbearing age and not using reliable contraception

• Participants who have postsurgical complications of the gastrointestinal tract that might impair absorption

• Participants who have any clinically relevant abnormalities of laboratory parameters

• Participants who have had a potent CYP1A2 metabolic inducer (e.g., carbamazepine; rifampin) or inhibitor (e.g., amiodarone; cimetidine; efavirenz; fluoroquinolone antibiotics; ticlopidine) added to and/or removed from their medication regimen in the past two weeks