Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

Psychotic Disorders Clinical Trial

Official title:

NMDA Enhancers in the Treatment of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328276
• Other study ID #: DMR93-IRB-119
• Secondary ID: NHRI-EX-94-9405P
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2006
• Last updated: May 18, 2006
• Start date: December 2004
• Est. completion date: December 2005

Study information

• Verified date: May 2006
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Health Research Institutes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychoses
• Psychotic Disorders
• Schizophrenia
• Schizophrenias
• Schizophrenic Disorders

Intervention

Drug:
• Sarcosine

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, China Medical University Hospital	Taichung

Sponsors (3)

Lead Sponsor	Collaborator
China Medical University Hospital	National Health Research Institutes, Taiwan, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Lane HY, Chang YC, Liu YC, Chiu CC, Tsai GE. Sarcosine or D-serine add-on treatment for acute exacerbation of schizophrenia: a randomized, double-blind, placebo-controlled study. Arch Gen Psychiatry. 2005 Nov;62(11):1196-204. — View Citation