Mode
Text Size
Log in / Sign up
N/A N=81 Randomized Double-blind Treatment

Remediation of Working Memory in Schizophrenia

Schizophrenia · Schizoaffective Disorder

Enrolled (actual)
81
Serious AEs
17.3%
Results posted
Apr 2016
Primary outcome: Primary: Cognitive Assessment - MATRICS Consensus Cognitive Battery — 40.08; 43.28; 39.80; 41.28 T-score — p=.06

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cognitive Remediation (Behavioral); Computer Skills (Behavioral)
Age
Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Apr 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Cognitive Assessment - MATRICS Consensus Cognitive Battery
40.08; 43.28; 39.80; 41.28 .06
SECONDARY
Functional Capacity - University of California, San Diego Performance-Based Skills Assessment
79.03; 78.78 .73

Summary

The primary aim of the study is to test the efficacy of a novel cognitive remediation intervention that targets working memory-related functions. To accomplish this goal, 80 volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive remediation condition that targets working memory or a computer skills training intervention that teaches computer applications. In both conditions participants will receive computer training three times a week for 4 months. The investigators hypothesize that patients who receive the cognitive remediation intervention will demonstrate significantly greater change on neuropsychological measures of working memory and executive abilities than patients who receive the computer skills course. In addition, the investigators hypothesize that the intervention-induced cognitive change will be associated with concurrent improvements in functional capacity and psychosocial functioning in the community. A second study goal is to examine the stability of the intervention-induced changes in cognition. Cognition and psychosocial functioning will be reassessed 4 and 8 months after treatment termination to examine the stability of treatment effects and to assess whether a less intense maintenance training (once a week sessions) provides any additional benefit to participants. Lastly, this study will examine in an exploratory manner whether there are individual differences in treatment response. The Val158Met polymorphism of the COMT gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. The study will test whether the COMT polymorphism is predictive of response to cognitive remediation.

Eligibility Criteria

Inclusion Criteria

  • Veterans with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  • No hospitalizations in the previous 4 weeks
  • No antipsychotic medication changes in the previous 4 weeks
  • Age 18-60
  • Does not meet DSM-IV criteria for substance dependence in the previous 6 months or substance abuse in the previous month

Exclusion Criteria

  • History of clinically significant head injury or neurological disease
  • Poor comprehension of the English language
  • History of diagnosis of mental retardation or pervasive developmental disorder
  • Unable to give informed consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00995553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search