A Comparison of Two Cognitive Batteries in People With Schizophrenia
NCT ID: NCT00499044
Last Updated: 2009-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2007-12-31
2009-03-31
Brief Summary
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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.
Detailed Description
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Cognitive Drug Research (CDR) is a United Kingdom-based company that has developed another battery of assessments capable of measuring cognitive function in patients with schizophrenia. Its 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.
Cognitive assessments are important in establishing the efficacy of medications and other therapeutic interventions for improving cognitive function in patients with schizophrenia. Furthermore, this cognitive functioning is correlated with patients' ability to operate in the real world. This study aims to examine the test-retest reliabilities of the CDR and MATRICS cognitive batteries, and thereby gauge their value for use in studies of cognitive functioning in people with schizophrenia. The investigators hypothesize that for patients with schizophrenia there will be a significant difference in the test-retest reliabilities between the two batteries. Additional aims are to investigate the extent to which MCCB and CDR measure functioning in specific cognitive domains and to investigate patient tolerability and overall practicality of each battery.
Visit 1 (1.5 hours): Baseline Measures and Screening
* Consent
* Review of medical chart to confirm DSM-IV diagnosis of schizophrenia/schizoaffective disorder (depressed type) and medical/psychiatric stability
* Demographic questionnaire
* Salivary drug test to exclude current use of PCP, cannabis, alcohol, cocaine, amphetamine, methamphetamine, and opiates
Visit 2 (2 hours): Clinical Assessment and Training
* Clinical Rating Scales: Scale for the Assessment of Negative Symptoms (SANS), Brief Psychiatric Rating Scale (BPRS), Quality of Life Scale (QLS)
* CDR training
Visits 3 and 4 (2.5 hours each): Patients are randomized into one of two groups:
Group 1
* Visit 3: CDR battery followed by MATRICS battery (with short break in between); Tolerability Scale after each battery.
* Visit 4 (two weeks after Visit 3): MATRICS battery followed by CDR battery (with short break in between); Tolerability Scale after each battery.
Group 2
* Visit 3: MATRICS battery followed by CDR battery (with short break in between); Tolerability Scale after each battery.
* Visit 4 (two weeks after Visit 3): CDR battery followed by MATRICS battery (with short break in between); Tolerability Scale after each battery.
Subjects will undergo a screening visit and chart review to assure the clinical appropriateness and safety of their participation. Subjects are free to withdraw from the study at any stage without giving a reason.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
MATRICS Consensus Cognitive Battery
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.
2
Cognitive Drug Research Computerized Cognitive Assessment System
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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North Suffolk Mental Health Association
OTHER
Responsible Party
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Massachusetts General Hospital
Principal Investigators
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A. Eden Evins, M.D., M.P.H.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Freedom Trail Clinic, Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr Res. 2004 Dec 15;72(1):41-51. doi: 10.1016/j.schres.2004.09.009.
Andreasen NC. The Scale for the Assessment of Negative Symptoms (SANS): conceptual and theoretical foundations. Br J Psychiatry Suppl. 1989 Nov;(7):49-58. No abstract available.
Heinrichs DW, Hanlon TE, Carpenter WT Jr. The Quality of Life Scale: an instrument for rating the schizophrenic deficit syndrome. Schizophr Bull. 1984;10(3):388-98. doi: 10.1093/schbul/10.3.388.
Cornblatt BA, Risch NJ, Faris G, Friedman D, Erlenmeyer-Kimling L. The Continuous Performance Test, identical pairs version (CPT-IP): I. New findings about sustained attention in normal families. Psychiatry Res. 1988 Nov;26(2):223-38. doi: 10.1016/0165-1781(88)90076-5.
Related Links
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CDR Computerized Assessment System
Other Identifiers
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CORRC #18-2007
Identifier Type: -
Identifier Source: org_study_id