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| Sponsor: | China Medical University Hospital |
|---|---|
| Collaborators: |
National Science Council, Taiwan National Health Research Institutes, Taiwan |
| Information provided by: | China Medical University Hospital |
| ClinicalTrials.gov Identifier: | NCT00491569 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | NMDA Enhancers in the Treatment of Schizophrenia: Sarcosine vs. D-Serine |
| Enrollment: | 60 |
| Study Start Date: | January 2005 |
| Study Completion Date: | December 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Taiwan | |
| China Medical University Hospital | |
| Taichung, Taiwan, 404 | |
| Principal Investigator: | Hsien-Yuan Lane, MD,PhD | Department of Psychiatry, China Medical University Hospital, Taiwan |
More Information
| Study ID Numbers: | NSC-94-2314-B-039-026 |
| Study First Received: | June 24, 2007 |
| Last Updated: | June 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00491569 History of Changes |
| Health Authority: | Taiwan: National Science Council |
|
Schizophrenia sarcosine D-serine NMDA |
|
Schizophrenia Pathologic Processes Disease |
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
