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Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

This study has been completed.
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by:
China Medical University Hospital Identifier:
First received: May 18, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted

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.

Condition Intervention Phase
Schizophrenias Psychoses Psychotic Disorders Schizophrenic Disorders Drug: Sarcosine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: NMDA Enhancers in the Treatment of Schizophrenia

Resource links provided by NLM:

Further study details as provided by China Medical University Hospital:

Estimated Enrollment: 20
Study Start Date: December 2004
Estimated Study Completion Date: December 2005
Detailed 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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00328276

Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
National Health Research Institutes, Taiwan
National Science Council, Taiwan
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00328276     History of Changes
Other Study ID Numbers: DMR93-IRB-119
Study First Received: May 18, 2006
Last Updated: May 18, 2006

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders processed this record on August 18, 2017