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!
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:
- Potentially pro-cognitive medications
- Anti-dementia medications
- Monoamine oxidase inhibitors
- Tricyclic antidepressants
Larry J. Seidman, Ph.D.
William Stone, Ph.D.
Annie St-Hilaire, Ph.D.
Tracy Auster, B.A.
To receive more information about this study or to discuss participation,
Annie St-Hilaire, Ph.D.