Validation of Intermediate Measures Study

The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) program is an NIMH initiative supported by a partnership of pharmaceutical companies that was initially developed to facilitate advancements in pharmacological agents for the treatment of cognitive impairments associated with schizophrenia. The first phase of the MATRICS program, which is now complete, yielded important advances including the selection of a standard cognitive battery for clinical trials of cognitive-enhancing treatments of schizophrenia. Cognitive improvements are obviously necessary, but according to the FDA, not sufficient for drug approval. In addition to changes in cognitive performance, the FDA requires improvements on functionally meaningful measures that have more face validity for consumers and clinicians than cognitive performance measures. Such measures are referred to as intermediate or co-primary measures because they assess capacities that lie between basic cognitive performance and complex community functioning. Regrettably, there is no currently accepted or fully validated co-primary measure. The reason that identifying reliable and valid intermediate measures is important is that changes in complex community functioning are unlikely to be seen in clinical trials of relatively short duration (e.g., less than 1 year). Such long trials are difficult to conduct and hence the development of measures that are associated with cognitive change in shorter term trials is very important. As part of the second phase of the MATRICS program (aka MATRICS-CT), we are conducting the Validation of Intermediate Measures (VIM) study to evaluate the reliability, validity, and appropriateness of potential intermediate measures of functional capacity and interview-based measures of cognition for use in clinical trials.

The VIM study is a multi-site study sponsored by the National Institute of Mental Health (NIMH). Four research sites will take part in this project: Harvard/BIDMC (comprising the CRC here at MMHC), UCLA, Uptown Research in Chicago, and Collaborative Neuroscience Network in Gardner Grove, CA. The CRC was chosen because of its successful participation in the first phase of the MATRICS program, which was successfully completed early during the summer of 2005. We owe an enormous amount of gratitude to the MMHC clinicians for their support and help!

Research Participation

Participation involves a screening visit as well as baseline visit(s) and 4-week follow-up visit(s). During the screening visit, which takes approximately 1 hour to complete, potential participants undergo an interview to determine eligibility to participate in the study. During the study visits, participants complete a series of interviews, tasks, and tests. The baseline visit(s) take approximately 5 hours to complete and the follow-up visit takes approximately 4 hours to complete. Participants earn $15 per hour, up to a total of $135 by the end of the study, depending on participation. To qualify for participation in the VIM study, participants need to meet the following criteria:

  • Diagnosis of schizophrenia
  • 18-60 years of age
  • Ability to understand English
  • No medication change in the last 2 months
  • No hospitalization in the last 3 months
  • No excessive alcohol or other drug use in the past 6 months
  • No serious medical or neurological condition that could interfere with valid assessment (such as epilepsy, multiple sclerosis)
  • No history of serious head injury
  • No pregnancy or nursing
  • Not currently taking any of the following medications:
    • Clozapine
    • Potentially pro-cognitive medications
    • Anti-dementia medications
    • Amphetamine
    • Lithium
    • Monoamine oxidase inhibitors
    • Tricyclic antidepressants

Study Staff

Principal Investigators
Larry J. Seidman, Ph.D.
William Stone, Ph.D.

Study Coordinator
Annie St-Hilaire, Ph.D.

Tracy Auster, B.A.

To receive more information about this study or to discuss participation, contact:
Annie St-Hilaire, Ph.D.