Biomarkers in Schizophrenia
| Status: | Archived |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2009 |
| End Date: | February 2011 |
Effect of an NMDA-based Intervention on Biomarker Measures of Cognitive Dysfunction in Schizophrenia
N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in
neurocognitive dysfunction associated with schizophrenia. Further, several novel
glutamate-based classes of compound are presently in development as potential novel
treatments for persistent negative and cognitive symptoms. The study will assess
effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a
mechanism for developing appropriate outcome batteries for future trials of novel compounds.
16 in- or outpatients with DSM-IV-TR schizophrenia or schizoaffective disorder and prominent
negative symptoms will be recruited for this study. This study will consist of a randomized
trial of D-serine (60 mg/kg/d) vs. placebo using a crossover design with a 2-week baseline
lead-in, and two 6-week intervention arms separated by a two week, placebo controlled
washout period. Biomarkers will be assessed at baseline for each treatment arm, acutely
(day 7) following treatment initiation, and following 6 weeks of treatment (6 biomarker
sessions total). Primary biomarker outcome measures will include 1) amplitude of the
mismatch negativity (MMN) waveform and 2) amplitude of the visual P1 potential. Symptomatic
outcome measures will include PANSS and composite score of the MATRICS neuropsychological
battery. The study will be supported from ongoing NIMH-funded Cooperative Drug Development
Grant (CDDG) to the PI.
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