Study of the Effect of Dosing on Clozapine Levels

NCT02286206 | Withdrawn Phase 4

• 1 other identifier: H14-01644
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this 15-day study are:

1. 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. 2.To determine if frequency of clozapine administration has an effect on:
3. 3.Symptoms of schizophrenia
4. 4.Adverse effects of clozapine
5. 5.Fasting blood glucose, lipids, creatinine, and urea
6. 6.Weight and waist circumference

Conditions

Psychotic Disorders; Schizophrenia

Keywords

Clozapine; Psychotropic Drugs; Antipsychotic Agents; Psychotic Disorders; Schizophrenia; Adverse Effects; Drug Monitoring

Outcome Measures

Primary Outcomes (1)

• Change from baseline in steady-state trough plasma concentrations of clozapine and norclozapine at Days 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).

  Days 0 (baseline), 7, and 14

Secondary Outcomes (4)

• Change from baseline in symptoms at Day 14.

  Day 0 (baseline) and 14

• Change from baseline in side effect burden at Day 14

  Days 0 (baseline) and 14

• Changes from baseline in laboratory measures at Day 14.

  Days 0 (baseline) and 14

• Change from baseline in weight and waist circumference at Day 14.

  Days 0 (baseline) and 14

Study Arms (1)

Clozapine bid

EXPERIMENTAL

Participants have been taking clozapine once daily and have reached steady-state prior to the start of this study. Intervention: Days 1-14

Drug: Clozapine

Interventions

Clozapine DRUG

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)

Also known as: Clozaril, FazaClo

Clozapine bid

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC Hospital - Detwiller Pavilion

Vancouver, British Columbia, V6T 2A1, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ric M. Procyshyn, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 7, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)