Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Antipsychotic Medication Extended Dosing Study

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00431574
First received: February 2, 2007
Last updated: February 25, 2008
Last verified: February 2008
  Purpose

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
Schizophrenia
Procedure: dosing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431574

Locations
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
Investigators
Principal Investigator: Gary J Remington, MD, PhD Centre for Addiction and Mental Health
  More Information

No publications provided by Centre for Addiction and Mental Health

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

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

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014