Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia - Full Text View

Sponsors and Collaborators:	China Medical University Hospital National Health Research Institutes, Taiwan National Science Council, Taiwan
Information provided by:	China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT00328276

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	NMDA Enhancers in the Treatment of Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Sarcosine

U.S. FDA Resources

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

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:

Lane HY, Chang YC, Liu YC, Chiu CC, Tsai GE. Sarcosine or D-serine add-on treatment for acute exacerbation of schizophrenia: a randomized, double-blind, placebo-controlled study. Arch Gen Psychiatry. 2005 Nov;62(11):1196-204.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lane HY, Liu YC, Huang CL, Chang YC, Liau CH, Perng CH, Tsai GE. Sarcosine (N-methylglycine) treatment for acute schizophrenia: a randomized, double-blind study. Biol Psychiatry. 2008 Jan 1;63(1):9-12. Epub 2007 Jul 20.

Study ID Numbers:	DMR93-IRB-119, NHRI-EX-94-9405PI
Study First Received:	May 18, 2006
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00328276 History of Changes
Health Authority:	Taiwan: National Health Research Institutes

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Pathologic Processes
Disease

Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 11, 2009