Back to resultsAntipsychotic Medication Extended Dosing Study
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
dosing
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective, antipsychotic, randomized control trial
Eligibility 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
Sites / Locations
- Centre for Addiction and Mental Health
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00431574
First Posted
February 2, 2007
Last Updated
February 25, 2008
Sponsor
Centre for Addiction and Mental Health
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT00431574
Brief Title
Antipsychotic Medication Extended Dosing Study
Official Title
Antipsychotic Medication Extended Dosing Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, schizoaffective, antipsychotic, randomized control trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
dosing
Primary Outcome Measure Information:
Title
Clinical Global Impression every 2 weeks
Title
Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks
Title
Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks
Title
Abnormal Involuntary Movement Scale every 2 weeks
Title
Drug Attitude Inventory every 2 weeks
Title
Calgary Depression Scale for Schizophrenia every 2 weeks
Title
Brief Psychiatric Rating Scale every 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary J Remington, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20868639
Citation
Remington G, Seeman P, Feingold A, Mann S, Shammi C, Kapur S. "Extended" antipsychotic dosing in the maintenance treatment of schizophrenia: a double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Aug;72(8):1042-8. doi: 10.4088/JCP.09m05866yel. Epub 2010 Sep 7.
Results Reference
derived
Learn more about this trial
Antipsychotic Medication Extended Dosing Study
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