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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 19, 2014