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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 October 2021 |
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Main ID: |
NCT02286206 |
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Date of registration:
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04/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of the Effect of Dosing on Clozapine Levels
PK-CLZ |
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Scientific title:
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A Pilot Study to Determine How Frequency of Administration Modifies Steady-State Plasma Concentrations of Orally Administered Clozapine |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02286206 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Randall White, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Alasdair Barr, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Ric M. Procyshyn, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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William Honer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psychotic Disorders
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Schizophrenia
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Intervention(s)
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Drug: Clozapine
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Primary Outcome(s)
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Change from baseline in steady-state trough plasma concentrations of clozapine and norclozapine at Days 7 and 14.
[Time Frame: Days 0 (baseline), 7, and 14]
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Secondary Outcome(s)
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Change from baseline in symptoms at Day 14.
[Time Frame: Day 0 (baseline) and 14]
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Change from baseline in weight and waist circumference at Day 14.
[Time Frame: Days 0 (baseline) and 14]
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Change from baseline in side effect burden at Day 14
[Time Frame: Days 0 (baseline) and 14]
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Changes from baseline in laboratory measures at Day 14.
[Time Frame: Days 0 (baseline) and 14]
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Secondary ID(s)
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H14-01644
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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