Sarcosine or D-Serine Add-on Treatment for Chronic Schizophrenia

This study has been completed.

Sponsor:

Collaborators:

National Science Council, Taiwan

National Health Research Institutes, Taiwan

Information provided by:

China Medical University Hospital

ClinicalTrials.gov Identifier:

NCT00491569

First received: June 24, 2007

Last updated: NA

Last verified: June 2007

History: No changes posted

Purpose

Both GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia patients.

The purpose of this study is to compare efficacy and safety of add-on treatment of sarcosine, a GlyT-1 inhibitor, and D-serine, an NMDA-glycine site agonist, in chronically stable schizophrenia patients who have been stabilized with antipsychotics.

Condition	Intervention	Phase
Schizophrenias Psychoses Psychotic Disorders Schizophrenic Disorders	Drug: Sarcosine and D-serine	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: Sarcosine vs. D-Serine

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Serine

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:

Total scores of Positive and Negative Syndrome Scale (PANSS) and Quality of Life (QOL) [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Subscales of PANSS [ Time Frame: 6 weeks ]

Enrollment:	60
Study Start Date:	January 2005
Study Completion Date:	December 2006

Detailed Description:

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 regarded as a novel treatment approach. To date, there have been several reported trials on NMDA enhancers. Both sarcosine (N-methylglycine, a glycine transporter I inhibitor) and D-serine (a potent NMDA-glycine site agonist) showed therapeutic effects in chronically stable patients. Interestingly, sarcosine appeared more efficacious than D-serine in acutely exacerbated ones when added-on to antipsychotics. Both sarcosine and D-serine yielded excellent safety profiles.

It remains unclear whether sarcosine can be also more efficacious than D-serine in the treatment for chronically stable schizophrenia. The aim of this project is to examine the efficacy and safety of add-on treatment of sarcosine vs. D-serine in chronically stable schizophrenia patients who have been stabilized with antipsychotics.

In the study, 60-75 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the three groups (2 gm/d sarcosine, 2 gm/d D-serine, or placebo) with a double-blind manner. Clinical manifestation (Positive and Negative Syndrome Scale [PANSS], side effects and quality of life (QOL) are evaluated every two weeks during the trial.. The efficacies of three groups are compared.

Eligibility

Ages Eligible for Study:	18 Years to 65 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).
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491569

Locations

Taiwan
China Medical University Hospital
Taichung, Taiwan, 404

Sponsors and Collaborators

China Medical University Hospital

National Science Council, Taiwan

National Health Research Institutes, Taiwan

Investigators

Principal Investigator:

Hsien-Yuan Lane, MD,PhD

Department of Psychiatry, China Medical University Hospital, Taiwan

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 ClinicalTrials.gov Identifier (NCT Number):

Lane HY, Lin CH, Huang YJ, Liao CH, Chang YC, Tsai GE. A randomized, double-blind, placebo-controlled comparison study of sarcosine (N-methylglycine) and D-serine add-on treatment for schizophrenia. Int J Neuropsychopharmacol. 2010 May;13(4):451-60. Epub 2009 Nov 4.

ClinicalTrials.gov Identifier:	NCT00491569 History of Changes
Other Study ID Numbers:	NSC-94-2314-B-039-026
Study First Received:	June 24, 2007
Last Updated:	June 24, 2007
Health Authority:	Taiwan: National Science Council

Keywords provided by China Medical University Hospital:

Schizophrenia
sarcosine
D-serine
NMDA

Additional relevant MeSH terms:

Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on June 13, 2013

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