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

Sarcosine as Primary or Adjunctive Therapy in Obsessive Compulsive Disorder: A Prospective, Open-label Study

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Drug: N-methyl glycine

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Yale-Brown Obsessive Compulsive Scale	week0, 2, 4, 6, 8, and 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Hamilton Anxiety Rating scale	week0, 2, 4, 6, 8, and 10

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: Taipei City Hospital
• Investigators: Study Chair: Guochuan E Tsai, MD, PhD, Department of Psychiatry, Harbor-UCLA Medical Center, California, U.S.A

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 13, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): December 29, 2009
• Last Update Submitted That Met QC Criteria: December 24, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: NMDA receptor; obsessive compulsive disorder; sarcosine; glycine transporter I
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Glycine Agents; Glycine
• Other Study ID Numbers: DMR96-IRB-75