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

Sponsor

China Medical University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01031927

Collaborator

Taipei City Hospital (Other)

Enrollment

Location

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Outcome Measures

Primary Outcome Measures

Yale-Brown Obsessive Compulsive Scale [week0, 2, 4, 6, 8, and 10]

Secondary Outcome Measures

Hamilton Anxiety Rating scale [week0, 2, 4, 6, 8, and 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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