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

Obsessive Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031927
• Other study ID #: DMR96-IRB-75
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2009
• Last updated: December 24, 2009
• Start date: June 2007

Study information

• Verified date: December 2009
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• N-methyl glycine
staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale		week0, 2, 4, 6, 8, and 10	No
Secondary	Hamilton Anxiety Rating scale		week0, 2, 4, 6, 8, and 10	No