A Comparison of Two Cognitive Batteries in People With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The National Institute of Mental Health's Measurement and Treatment Research to Improve
      Cognition in Schizophrenia (MATRICS) program was a collaboration between members of academia,
      industry, and the government, with the goal of furthering the development of drugs for the
      treatment of the cognitive deficits of schizophrenia. The program led to the creation of the
      MATRICS Consensus Cognitive Battery (MCCB), which 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 (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.
    

Intervention name(s): CDR Computerized Cognitive Assessment System; MATRICS Consensus Cognitive Battery
Intervention type(s): Other; Other
Intervention description(s): 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.; 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 name(s): CDR; MCCB; MATRICS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: cognition; attention; memory; concentration; schizophrenia