Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

Sponsor

China Medical University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00328276

Collaborator

National Health Research Institutes, Taiwan (Other), National Science Council, Taiwan (Other)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenias Psychoses Psychotic Disorders Schizophrenic Disorders	Drug: Sarcosine	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

NMDA Enhancers in the Treatment of Schizophrenia

Study Start Date :

Dec 1, 2004

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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