A Comparison of Two Cognitive Batteries in People With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00499044|
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : November 26, 2009
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 or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Other: CDR Computerized Cognitive Assessment System Other: MATRICS Consensus Cognitive Battery||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||CDR Versus MATRICS Cognitive Batteries in Patients With Schizophrenia|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
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.
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
- Test-retest reliabilities of MATRICS Consensus Cognitive Battery (MCCB) and the Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [ Time Frame: 4 weeks ]
- Cognitive domains measured by MCCB versus CDR [ Time Frame: 4 weeks ]
- Correlation of MCCB versus CDR scores with clinical measures of quality of life [ Time Frame: 4 weeks ]
- Self-reported tolerability and satisfaction of the MCCB and CDR assessments [ Time Frame: 4 weeks ]
- Practicality of MCCB versus CDR as reported by test administrators [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499044
|United States, Massachusetts|
|Freedom Trail Clinic, Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||A. Eden Evins, M.D., M.P.H.||Massachusetts General Hospital|