Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

China Medical University

Status and phase

Completed

Phase 2

Conditions

Schizophrenic Disorders

Psychotic Disorders

Schizophrenias

Psychoses

Treatments

Drug: Sarcosine

Study type

Interventional

Funder types

Other

Identifiers

NCT00328276

DMR93-IRB-119

NHRI-EX-94-9405PI

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
Free from antipsychotics for at least 7 days before enrollment.
Agree to participate in the study and provide informed consent

Exclusion criteria

Meet DSM-IV criteria of major mood disorder, current substance dependence or mental retardation
History of epilepsy, head trauma or CNS diseases
Major, untreated medical diseases
Pregnancy or lactation
Receiving psychotropic agents or depot within three months prior to study entry