Psychotic Disorders Clinical Trial
Official title:
NMDA Enhancers in the Treatment of 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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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