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Antipsychotic Medication Extended Dosing Study

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ClinicalTrials.gov Identifier: NCT00431574
Recruitment Status : Completed
First Posted : February 6, 2007
Last Update Posted : February 26, 2008
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Centre for Addiction and Mental Health

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Procedure: dosing Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Antipsychotic Medication Extended Dosing Study
Study Start Date : August 2002
Actual Primary Completion Date : June 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Clinical Global Impression every 2 weeks
  2. Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks
  3. Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks
  4. Abnormal Involuntary Movement Scale every 2 weeks
  5. Drug Attitude Inventory every 2 weeks
  6. Calgary Depression Scale for Schizophrenia every 2 weeks
  7. Brief Psychiatric Rating Scale every 2 weeks

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: February 26, 2008
Last Verified: February 2008

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs