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Antipsychotic Medication Extended Dosing Study

This study has been completed.
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Centre for Addiction and Mental Health Identifier:
First received: February 2, 2007
Last updated: February 25, 2008
Last verified: February 2008
In patients stabilized on their antipsychotic and demonstrating evidence of good clinical response, there will not be a significant change in symptoms if their medication is decreased to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a reduction in side effects, as well as improved subjective response to treatment.

Condition Intervention
Procedure: dosing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Antipsychotic Medication Extended Dosing Study

Resource links provided by NLM:

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Clinical Global Impression every 2 weeks
  • Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks
  • Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks
  • Abnormal Involuntary Movement Scale every 2 weeks
  • Drug Attitude Inventory every 2 weeks
  • Calgary Depression Scale for Schizophrenia every 2 weeks
  • Brief Psychiatric Rating Scale every 2 weeks

Estimated Enrollment: 40
Study Start Date: August 2002
Study Completion Date: October 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:
The present study is a 6-month, double-blind study of patients with schizophrenia stabilized on their current antipsychotic (monotherapy) for a period of at least 3 months. After providing informed consent, individuals will be randomly assigned to 1 of 2 treatment arms: regular daily antipsychotic dosing or active medication at the same daily dose every 2nd day. Various scales to measure clinical response and side effects will be administered at baseline, as well as every 2 weeks thereafter. Subjective scales will also be employed, and lab evaluations will include plasma antipsychotic levels at baseline and endpoint, as well as prolactin. Our sample size will be 20/group.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia or schizo-affective disorder
  • Capacity to provide written, informed consent
  • Stabilized* on a single oral antipsychotic for at least three months (excluding CLOZAPINE or QUETIAPINE)
  • Evidence of compliance with previous antipsychotic treatment, i.e. greater than 90% * defined as 2 consecutively identical CGI evaluations (screening and baseline, at least one week apart)

Exclusion Criteria:

  • exposure to depot antipsychotic during 12 months prior to enrollment
  • substance-related disorders according to DSM-IV
  Contacts and Locations
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Please refer to this study by its identifier: NCT00431574

Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Gary J Remington, MD, PhD Centre for Addiction and Mental Health
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Gary Remington, Centre for Addiction and Mental Health Identifier: NCT00431574     History of Changes
Other Study ID Numbers: 234/2003
Study First Received: February 2, 2007
Last Updated: February 25, 2008

Keywords provided by Centre for Addiction and Mental Health:
randomized control trial

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 25, 2017