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Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00328276
First Posted: May 19, 2006
Last Update Posted: May 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by:
China Medical University Hospital
  Purpose

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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328276


Locations
Taiwan
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
Investigators
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00328276     History of Changes
Other Study ID Numbers: DMR93-IRB-119
NHRI-EX-94-9405PI
First Submitted: May 18, 2006
First Posted: May 19, 2006
Last Update Posted: May 19, 2006
Last Verified: May 2006

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders