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Antipsychotic Medication Extended Dosing Study
This study has been completed.
Sponsor:
Centre for Addiction and Mental Health
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
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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 Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
| Official Title: | Antipsychotic Medication Extended Dosing Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
U.S. FDA Resources
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) |
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 (Adult, Senior) |
| 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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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
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
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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017