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Trial record 43 of 2595 for:    NMDA

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491569
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : June 26, 2007
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Information provided by:
China Medical University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Schizophrenias Psychoses Psychotic Disorders Schizophrenic Disorders Drug: Sarcosine and D-serine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: NMDA Enhancers in the Treatment of Schizophrenia: Sarcosine vs. D-Serine
Study Start Date : January 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Serine

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

Secondary Outcome Measures :
  1. Subscales of PANSS [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491569

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China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
National Science Council, Taiwan
National Health Research Institutes, Taiwan
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Principal Investigator: Hsien-Yuan Lane, MD,PhD Department of Psychiatry, China Medical University Hospital, Taiwan

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00491569     History of Changes
Other Study ID Numbers: NSC-94-2314-B-039-026
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: June 26, 2007
Last Verified: June 2007
Keywords provided by China Medical University Hospital:
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders