Clinical trial NCT00995553: Remediation of Working Memory in Schizophrenia
Official title: Remediation of Working Memory in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Veterans Medical Research Foundation
name: Minneapolis Veterans Affairs Medical Center
First posted: 2009-10-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Cognitive Assessment - MATRICS Consensus Cognitive Battery
timeFrame: Post-intervention, within 2 weeks of completion of the 4 month intervention
Secondary outcomes:
measure: Functional Capacity - University of California, San Diego Performance-Based Skills Assessment
timeFrame: Post-intervention, within 2 weeks of completion of the 4 month intervention
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Tasha Marie Nienow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramsay IS, Nienow TM, Marggraf MP, MacDonald AW. Neuroplastic changes in patients with schizophrenia undergoing cognitive remediation: triple-blind trial. Br J Psychiatry. 2017 Mar;210(3):216-222. doi: 10.1192/bjp.bp.115.171496. Epub 2017 Feb 2.