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A Comparison of Two Cognitive Batteries in People With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00499044
First received: July 9, 2007
Last updated: November 25, 2009
Last verified: November 2009
History of Changes
  Purpose

The investigators will compare the test-retest reliabilities of two cognitive batteries in people with schizophrenia: Cognitive Drug Research Computerized Cognitive Assessment System ("CDR") and MATRICS Consensus Cognitive Battery ("MCCB"). The investigators hypothesize that there will be a statistically significant difference in the test-retest reliabilities between MCCB and CDR. In addition, the investigators hypothesize that each of the two batteries will better measure certain areas of cognition. The investigators also hypothesize that scores from both batteries will correlate with quality of life scores, and that there will be a significant difference between the correlations of MCCB and CDR. The investigators hypothesize there will be a significant difference in patients' self-reported tolerability and satisfaction of the MATRICS versus CDR assessments. Lastly, the investigators hypothesize that there will be a significant difference in the MATRICS versus CDR batteries with respect to an administrator-rated score of practicality.

Approximately 32 subjects will enroll in the study. Following consent and eligibility screening (visit 1) and baseline clinical assessment and training in the use of the CDR battery (visit 2), subjects will be randomized into one of two groups for visits 3 and 4. One group will complete the CDR and then MCCB in visit 3, as well as the Tolerability Scale for each battery. The other group will complete the batteries in reverse order during visit 3. Each group will complete both batteries again in reverse order for visit 4. Randomization will be done in blocks of 2. After completion of every 4 subjects, study administrators will complete the Practicality Scale for each battery.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
 Other: CDR Computerized Cognitive Assessment System
Other: MATRICS Consensus Cognitive Battery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: CDR Versus MATRICS Cognitive Batteries in Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Memory Schizophrenia
U.S. FDA Resources

Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:
  • Test-retest reliabilities of MATRICS Consensus Cognitive Battery (MCCB) and the Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive domains measured by MCCB versus CDR [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Correlation of MCCB versus CDR scores with clinical measures of quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Self-reported tolerability and satisfaction of the MCCB and CDR assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Practicality of MCCB versus CDR as reported by test administrators [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: December 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MATRICS Consensus Cognitive Battery
 Other: MATRICS Consensus Cognitive Battery
The MATRICS Consensus Cognitive Battery measures functioning across various cognitive domains, such as attention, working memory (verbal and nonverbal), learning (verbal and visual), reasoning and problem solving, and social cognition. Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes.
Other Names:
  • MCCB
  • MATRICS
Experimental: 2
Cognitive Drug Research Computerized Cognitive Assessment System
 Other: CDR Computerized Cognitive Assessment System
Cognitive Drug Research Computerized Cognitive Assessment System consists of performance tasks that measure reaction time, numeric and spatial working memory, word and picture recall and recognition, and episodic secondary memory. CDR is a single, unified battery that can be stored and administered using a laptop computer.
Other Name: CDR

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women and men aged 18-65 with DSM-IV diagnosis of schizophrenia or schizoaffective disorder (depressed type) by diagnostic interview and chart review.
  2. Clinically stable on a stable dose of antipsychotic medication for at least one month; no current active suicidal ideation.
  3. Not treated with investigational medication in the past 30 days.
  4. Competent to provide informed consent.

Exclusion Criteria:

  1. Diagnosis of dementia, neurodegenerative disease, seizure disorder, current substance abuse or dependence disorders, including alcohol, active within the last 3 months or any Axis I DSM-IV diagnosis other than schizophrenia or schizoaffective disorder (depressed type).
  2. Serious illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease that is not stabilized such that hospitalization for treatment of that illness is likely within the next two months.
  3. Patients who, in the investigator's opinion, pose a current severe homicide or suicide risk.
  4. History of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499044

Locations
United States, Massachusetts
Freedom Trail Clinic, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
North Suffolk Mental Health Association
Investigators
Principal Investigator: A. Eden Evins, M.D., M.P.H. Massachusetts General Hospital
  More Information

Additional Information:
CDR Computerized Assessment System  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: A. Eden Evins, M.D., M.P.H., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00499044     History of Changes
Other Study ID Numbers: CORRC #18-2007
Study First Received: July 9, 2007
Last Updated: November 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by North Suffolk Mental Health Association:
cognition
attention
memory
concentration
schizophrenia

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013