drugset / Trial / NCT00817336

Biomarkers in Schizophrenia

NCT00817336 ↗

Phase 2 Completed 16 enrolled Nathan Kline Institute for Psychiatric Research
RandomizedCrossoverQuadruple-blindTreatment

Summary

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.

Timeline

Start
2009-06
Primary completion
2011-07
Completion
2011-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); D-serine vs Placebo; p = 0.02; Cohen's d 0.80; Mixed Models Analysis NCT00817336 ↗

paper RESULTS: Double-blind d-serine treatment led to significant improvement in MMN frequency (p=0.001, d=2.3) generation and clinical symptoms (p=0.023, d=0.80). PMID 28318835 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject D-serine Unknown 60 mg/kg —