- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00328276
Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia
NMDA Enhancers in the Treatment of Schizophrenia
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Taichung, Taiwan, 404
- Department of Psychiatry, China Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
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
Publications and helpful links
General 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. doi: 10.1001/archpsyc.62.11.1196.
- 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. doi: 10.1016/j.biopsych.2007.04.038. Epub 2007 Jul 20.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMR93-IRB-119
- NHRI-EX-94-9405PI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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