Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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In the study, 20 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the two groups (1 g/d and 2 g/d) with a double-blind manner. Clinical manifestation (Positive and Negative Syndrome Scale; Scale for the Assessment of Negative Symptoms), side effects and quality of life are evaluated every two weeks during the trial. The efficacies of two groups are compared, and the characteristics of better responders are analyzed.

Conditions

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Schizophrenias Psychoses Psychotic Disorders Schizophrenic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sarcosine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Hsien-yuan Lane, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Guochuan E. Tsai, MD,PhD

Role: STUDY_DIRECTOR

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

Locations

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Department of Psychiatry, China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND

PMID: 16275807 (View on PubMed)

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.

Reference Type DERIVED

PMID: 17659263 (View on PubMed)

Other Identifiers

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NHRI-EX-94-9405PI

Identifier Type: -

Identifier Source: secondary_id

DMR93-IRB-119