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

This study has been completed.
Sponsor:
Collaborator:
Taipei City Hospital
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01031927
First received: December 13, 2009
Last updated: December 24, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
 Drug: N-methyl glycine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sarcosine as Primary or Adjunctive Therapy in Obsessive Compulsive Disorder: A Prospective, Open-label Study

Resource links provided by NLM:

Drug Information available for: Glycine
U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: week0, 2, 4, 6, 8, and 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Anxiety Rating scale [ Time Frame: week0, 2, 4, 6, 8, and 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2007
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: N-methyl glycine
    staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day
    Other Name: sarcosine
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031927

Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Taipei City Hospital
Investigators
Study Chair: Guochuan E Tsai, MD, PhD Department of Psychiatry, Harbor-UCLA Medical Center, California, U.S.A
  More Information

No publications provided

Responsible Party: Po-Lun Wu, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01031927     History of Changes
Other Study ID Numbers: DMR96-IRB-75
Study First Received: December 13, 2009
Last Updated: December 24, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
obsessive compulsive disorder
sarcosine
glycine transporter I
NMDA receptor

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Glycine
Glycine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013