Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00328276
First received: May 18, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: May 18, 2006
Last Updated: May 18, 2006
Health Authority: Taiwan: National Health Research Institutes

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Disease
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014