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Study of the Effect of Dosing on Clozapine Levels

NCT02286206 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-10-08

No results posted yet for this study

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Ric M. Procyshyn, Ph.D · University of British Columbia

  • Alasdair Barr, Ph.D · University of British Columbia

  • William Honer, MD · University of British Columbia

  • Randall White, MD · University of British Columbia

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286206 on ClinicalTrials.gov