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

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ClinicalTrials.gov Identifier: NCT01031927
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : December 29, 2009
Sponsor:
Collaborator:
Taipei City Hospital
Information provided by:
China Medical University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: N-methyl glycine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sarcosine as Primary or Adjunctive Therapy in Obsessive Compulsive Disorder: A Prospective, Open-label Study
Study Start Date : June 2007
Actual Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Glycine

Arms and Interventions
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Intervention Details:
  • Drug: N-methyl glycine
    staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day
    Other Name: sarcosine

Outcome Measures
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Primary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale [ Time Frame: week0, 2, 4, 6, 8, and 10 ]

Secondary Outcome Measures :
  1. Hamilton Anxiety Rating scale [ Time Frame: week0, 2, 4, 6, 8, and 10 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Po-Lun Wu, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01031927     History of Changes
Other Study ID Numbers: DMR96-IRB-75
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: December 2009

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

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
 Anxiety Disorders
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs