Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

NCT00328276 | Completed Phase 2

• 2 other identifiers: DMR93-IRB-119NHRI-EX-94-9405PI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenias; Psychoses; Psychotic Disorders; Schizophrenic Disorders

Interventions

Sarcosine DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 16275807 BACKGROUND

• 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.

  PMID: 17659263 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Sarcosine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

N-substituted Glycines; Glycine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Hsien-yuan Lane, MD,PhD

  Dept. of Psychiatry, China Medical University Hospital, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

• Guochuan E. Tsai, MD,PhD

  Department of Psychiatry, Harbor-UCLA Medical Center, Torrance, California

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: December 1, 2004
• Study Completion: December 1, 2005
• Last Updated: May 19, 2006

Record last verified: 2006-05

Locations

TW (1)