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Enhancing the Outcome of Skills Training for People With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00069433
Recruitment Status : Completed
First Posted : October 9, 2003
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):

September 24, 2003
October 9, 2003
September 24, 2013
April 2001
November 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00069433 on ClinicalTrials.gov Archive Site
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Enhancing the Outcome of Skills Training for People With Schizophrenia
Skills Training for Schizophrenia: Enhancing Outcomes
This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world."

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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Procedure: Social skills and symptom management training
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2005
November 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH066362 ( U.S. NIH Grant/Contract )
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New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
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New York State Psychiatric Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP