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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014