- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069433
Enhancing the Outcome of Skills Training for People With Schizophrenia
Skills Training for Schizophrenia: Enhancing Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People with schizophrenia have a large number of social and symptom management training programs available to them. Studies suggest that these training programs are effective, but their generalizability and effectiveness in outpatient settings has not been thoroughly examined. This study will examine the treatment outcomes of a skills training approach in schizophrenic individuals taking antipsychotic medication.
Participants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly assigned to receive either intensive symptom management and social skills training or group therapy for 12 months. A verbal memory test will be used to stratify the randomization procedure and to control for neurocognitive functioning.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- Hall-Brooke-The Center
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Westport, Connecticut, United States, 06880
- Hall-Brooke Behavioral Health Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of schizophrenia or schizoaffective disorder for > 5 years
- Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes
- Social Behavior Scale (SBS) score > 45
- Willing and able to provide informed consent
Exclusion Criteria:
- Intelligence Quotient < 70
- Use of more than one antipsychotic medication
- Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
- Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence
- History of any traumatic brain injury leading to loss of consciousness for > 30 minutes
- Diagnosis of a comorbid medical condition that could interfere with antipsychotic medication treatment or the ability to complete the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #4339
- DSIR AT-SP
- R01MH066362 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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