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Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

NCT00328276 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2006-05-19

No results posted yet for this study

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.

Conditions

  • Schizophrenias
  • Psychoses
  • Psychotic Disorders
  • Schizophrenic Disorders

Interventions

DRUG

Sarcosine

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Hsien-yuan Lane, MD,PhD · Dept. of Psychiatry, China Medical University Hospital, Taichung, Taiwan

  • Guochuan E. Tsai, MD,PhD · Department of Psychiatry, Harbor-UCLA Medical Center, Torrance, California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Completion
2005-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00328276 on ClinicalTrials.gov