Remediation of Working Memory in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Remediation of Working Memory in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995553
• Other study ID #: D6981-R
• Secondary ID: 1I01RX000180-01
• Status: Completed
• Phase: N/A
• First received: October 14, 2009
• Last updated: January 22, 2016
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Cognitive Remediation
This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months.
• Computer Skills
This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Minneapolis Veterans Affairs Medical Center, Veterans Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Assessment - MATRICS Consensus Cognitive Battery and N-back tasks		Pre-and Post-intervention and 4 and 8-month follow-up	No
Secondary	Functional Capacity - University of California, San Diego Performance-Based Skills Assessment and Social Skills Performance Assessment Community Functioning - Social Functioning Scale		Pre-and Post-intervention and 4 and 8-month follow-up	No