Status:

COMPLETED

Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network

Lead Sponsor:

National Institute of Mental Health (NIMH)

Conditions:

Schizophrenia

Eligibility:

All Genders

18-55 years

Phase:

PHASE4

Brief Summary

This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.

Detailed Description

Neurocognitive impairments, or problems with thinking and brain function, are a core component of schizophrenia. Such impairments, which can range from moderate to severe, are strongly associated with...

Eligibility Criteria

Inclusion

  • Demonstrates adequate decisional capacity to make a choice about participating in the research study
  • Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
  • Positive and Negative Syndrome Scale (PANSS) hallucinatory behavior, unusual thought content, and conceptual disorganization ratings of no greater than moderately severe (i.e., item scores must be less than or equal to 5)
  • Meets all of the following cognitive performance and English language criteria:
  • Learned English before age 12
  • Able to complete the baseline Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) validly, based on the judgment of the investigator
  • Raw score of 37 or greater on the Wide Range Achievement Test, reading subtest, 3rd edition (WRAT-3), used to establish minimum sixth grade reading level and estimated premorbid IQ
  • Able to state specific goals relevant to the intervention that participant would like to achieve
  • Able to participate in the computerized intervention, based on the judgment of the investigator

Exclusion

  • Psychiatric hospitalization within 8 weeks of random assignment
  • Adjustment to antipsychotic treatment within 4 weeks of random assignment
  • Currently taking an anticholinergic medication
  • DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
  • History of mental retardation, pervasive developmental disorder, or other neurological disorder (such as a traumatic brain injury, epilepsy, or Parkinson 's disease)

Key Trial Info

Start Date :

July 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2010

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT00930150

Start Date

July 1 2009

End Date

February 1 2010

Last Update

April 19 2011

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Yale University/Connecticut Mental Health Center

New Haven, Connecticut, United States, 06519

2

Emory University

Atlanta, Georgia, United States, 30329

3

Medical College of Georgia

Augusta, Georgia, United States, 30912

4

University of Iowa Hospital

Iowa City, Iowa, United States, 52242

Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network | DecenTrialz