NCT Number: NCT00295048
Cognitive Remediation for Schizophrenia
The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for individuals with schizophrenia and related disorders.
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Notify MeKey information
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Maryland - Walter P. Carter Center, Baltimore, Maryland, United States
About this study
Schizophrenia is associated with neurocognitive impairment, diminished life satisfaction, lack of independence, and poor functioning in social, occupational and other desired and expected community roles. The personal, social and economic costs of this illness are enormous. Neurocognitive deficits (e.g., slowed thinking, poor attention and memory, inadequate problem solving) are now recognized as core features of the illness, and primary contributors to functional impairment among patients (Bellack, Gold & Buchanan; 1999; Green, 1996). While standard antipsychotic medications improve psychotic symptomatology in many patients, their impact on neurocognition is modest, at best, and dramatic functional deficits remain even after adequate pharmacological treatment (Keefe et al., 1999). Hence, there is growing interest in alternative treatment strategies to address cognitive deficits, including computer-assisted cognitive remediation.
The purpose of this project is to assess the efficacy of a computer-assisted cognitive remediation program we have developed: Computer Assisted Cognitive Remediation (CACR). Fifty individuals with schizophrenia and related disorders will be recruited and randomly assigned to one of two conditions: a) 36 sessions of CACR; or b) 36 sessions of a manualized computer control condition (RC). The efficacy of CACR will be assessed on behavioral performance in three dimensions: (1) on the trained learning exercises, (2) on neuropsychological measures, and (3) on role play based assessments of everyday problem solving. We hypothesize that CACR will be more effective than the control treatment in each domain.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-IV criteria
- Age 18 through 50
- Subjects will be clinically stable as judged by current outpatient or inpatient treatment staff
- Primary psychiatric medication is a new generation antipsychotic other than Clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. of less of haloperidol for one month prior to enrollment.
Exclusion criteria
- Documented history of organic brain disease
- Documented history of mental retardation
- Physical limitations (e.g., with hearing or vision) that would interfere substantially with use of computer-based exercises
- Diagnosis of current Substance Dependence according to DSM-IV criteria
- Participation in the prior full trial of this remediation program (this exclusion is meant to apply to individuals participating in the full controlled trial, and not to individuals participating in the preliminary sub-study).
Treatment and study plan
Primary outcomes
-
broad cognitive performance (as indexed by a composite of the neuropsychological measures) and on a composite of everyday problem solving
Secondary outcomes
-
individual cognitive domains and individual everyday problem solving domains, the interaction of treatment with various other variables
Sponsors and collaborators
Lead sponsor
University of Maryland, Baltimore
Other
Collaborators
- National Institute of Mental Health (NIMH)
- VISN 5 Mental Illness Research, Education and Clinical Center
Registry information
Important dates
- Study start
- 2004
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Feb 22, 2006
- Registry last updated
- Jul 21, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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