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

Phase 2

Completed

• Conditions: Obsessive Compulsive Disorder

• Registration Number: NCT01031927
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2009-02
• Status Verified: 2009-12
• Study First Submitted: 2009-12-13
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Last Update Submitted: 2009-12-24
• Last Update Posted: 2009-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale	week0, 2, 4, 6, 8, and 10

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating scale	week0, 2, 4, 6, 8, and 10

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan