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Study of the Effect of Dosing on Clozapine Levels (PK-CLZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02286206
Recruitment Status : Unknown
Verified November 2017 by Ric Procyshyn, University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2014
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ric Procyshyn, University of British Columbia

Tracking Information
First Submitted Date  ICMJE November 4, 2014
First Posted Date  ICMJE November 7, 2014
Last Update Posted Date November 29, 2017
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
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 ]
Steady-state trough plasma concentrations of clozapine and norclozapine will be measured on Days 7 and 14 and compared to those obtained on Day 0 (baseline).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
  • Change from baseline in symptoms at Day 14. [ Time Frame: Day 0 (baseline) and 14 ]
    As assessed by structured clinical interviews for the Positive and Negative Syndrome Scale (PANSS)
  • Change from baseline in side effect burden at Day 14 [ Time Frame: Days 0 (baseline) and 14 ]
    As assessed by the Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
  • Changes from baseline in laboratory measures at Day 14. [ Time Frame: Days 0 (baseline) and 14 ]
    Laboratory measures include fasting blood glucose, fasting lipid profile, creatinine, and urea.
  • Change from baseline in weight and waist circumference at Day 14. [ Time Frame: Days 0 (baseline) and 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Effect of Dosing on Clozapine Levels
Official Title  ICMJE A Pilot Study to Determine How Frequency of Administration Modifies Steady-State Plasma Concentrations of Orally Administered Clozapine
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 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
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 evaluating whether twice daily administration of clozapine is better than once daily administration in terms of effectiveness and tolerability. Although this may seem trivial at first, when we consider that clozapine has a relatively short half-life and dissociates quickly from the dopamine D2 receptor, it justifies further consideration. It takes on even more significance knowing that the established threshold clozapine plasma concentration for therapeutic response (i.e., 350-420 ng/ml) was determined using steady-state trough plasma samples (i.e., approximately 12 hours after the evening dose) in patients administered clozapine twice rather than once daily.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Psychotic Disorders
  • Schizophrenia
Intervention  ICMJE Drug: Clozapine
One-half baseline dose po bid (or one-third baseline dose po qam and two-thirds baseline dose po qhs at the discretion of the treating clinicians and principal investigator)
Other Names:
  • Clozaril
  • FazaClo
Study Arms  ICMJE Experimental: Clozapine bid

Participants have been taking clozapine once daily and have reached steady-state prior to the start of this study.

Intervention: Days 1-14

Intervention: Drug: Clozapine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 4, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02286206
Other Study ID Numbers  ICMJE H14-01644
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ric Procyshyn, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ric M. Procyshyn, Ph.D University of British Columbia
Study Director: Alasdair Barr, Ph.D University of British Columbia
Study Director: William Honer, MD University of British Columbia
Study Director: Randall White, MD University of British Columbia
PRS Account University of British Columbia
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP