drugset / Trial / NCT00328276

Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

NCT00328276

RandomizedParallel-groupDouble-blindTreatment

Summary

The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has been considered as a novel treatment approach. To date, there have been several trials on NMDA enhancers reported. For example, sarcosine (N-methylglycine, a glycine transporter I inhibitor) showed therapeutic effects not only in chronically stable patients but also in acutely exacerbated ones when added-on to antipsychotics. In addition, sarcosine yields excellent safety profiles, in comparison to current antipsychotics. It remains unclear whether NMDA enhancers, such as sarcosine, can serve as monotherapy for schizophrenia. The aims of this project are to examine the efficacy and safety of sarcosine monotherapy for acutely-ill schizophrenic patients, and to compare the effects of 2 grams/day, effective dose, with 1 gram/day, ineffective lower dose.

Timeline

Start
2004-12
Primary completion
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Sarcosine Other / unclassified 1 g
Subject Sarcosine Other / unclassified 2 g

Indications