Status:
WITHDRAWN
Study of the Effect of Dosing on Clozapine Levels
Lead Sponsor:
University of British Columbia
Conditions:
Psychotic Disorders
Schizophrenia
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
It is important that clinicians do everything possible to optimize the use of clozapine in individuals with treatment-resistant schizophrenia. To our knowledge, there are no published studies evaluati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02286206
Start Date
January 1 2015
End Date
December 1 2017
Last Update
October 8 2021
Active Locations (1)
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1
UBC Hospital - Detwiller Pavilion
Vancouver, British Columbia, Canada, V6T 2A1