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N-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)

NCT ID: NCT01031927

Last Updated: 2009-12-29

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

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Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of obsessive compulsive disorder (OCD). Sarcosine, also known as N-methylglycine, is an endogenous antagonist of glycine transporter-I (GlyT-I), which potentiates glycine's action at the glycine site of N-methyl-D-aspartate (NMDA) receptors. In this 10-week open-label trial, we examined the efficacy and safety of sarcosine treatment in OCD patients.

Detailed Description

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Conditions

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Obsessive Compulsive Disorder

Keywords

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obsessive compulsive disorder sarcosine glycine transporter I NMDA receptor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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N-methyl glycine

staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day

Intervention Type DRUG

Other Intervention Names

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sarcosine

Eligibility Criteria

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Inclusion Criteria

* a primary OCD according to DSM-IV
* at least 1 year's duration of OC symptoms and a minimum severity score of ≥16 on Yale-Brown Obsessive Compulsive Scale
* drug naïve at study entry or
* being free from psychotropic medication for at least 8 weeks at study entry,or
* inadequately responded to ongoing psychotropic medications at study entry (defined by a Y-BOCS score of ≧16 despite treatment with maximum tolerated dose of a SRI medication for at least 8 weeks)

Exclusion Criteria

* patients with moderate to severe depression defined by a 21-item Hamilton Depression Rating Scale score of \>17,
* a history of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychosis as defined by DSM-IV, or if they were at significant risk of suicide, and
* with clinically significant organic disease including cardiovascular, hepatic, pulmonary, neurologic, metabolic, or renal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei City Hospital

OTHER_GOV

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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China Medical University Hospital

Principal Investigators

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Guochuan E Tsai, MD, PhD

Role: STUDY_CHAIR

Department of Psychiatry, Harbor-UCLA Medical Center, California, U.S.A

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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DMR96-IRB-75

Identifier Type: -

Identifier Source: org_study_id