Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||NMDA Enhancers in the Treatment of Schizophrenia|
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||December 2005|
In the study, 20 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the two groups (1 g/d and 2 g/d) with a double-blind manner. Clinical manifestation (Positive and Negative Syndrome Scale; Scale for the Assessment of Negative Symptoms), side effects and quality of life are evaluated every two weeks during the trial. The efficacies of two groups are compared, and the characteristics of better responders are analyzed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328276
|Department of Psychiatry, China Medical University Hospital|
|Taichung, Taiwan, 404|
|Principal Investigator:||Hsien-yuan Lane, MD,PhD||Dept. of Psychiatry, China Medical University Hospital, Taichung, Taiwan|
|Study Director:||Guochuan E. Tsai, MD,PhD||Department of Psychiatry, Harbor-UCLA Medical Center, Torrance, California|