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

NCT01031927 | Completed Phase 2 DMC

• 1 other identifier: DMR96-IRB-75
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

obsessive compulsive disorder; sarcosine; glycine transporter I; NMDA receptor

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale

  week0, 2, 4, 6, 8, and 10

Secondary Outcomes (1)

• Hamilton Anxiety Rating scale

  week0, 2, 4, 6, 8, and 10

Interventions

N-methyl glycine DRUG

staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day

Also known as: sarcosine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead
• Taipei City Hospital: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Sarcosine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

N-substituted Glycines; Glycine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Guochuan E Tsai, MD, PhD

  Department of Psychiatry, Harbor-UCLA Medical Center, California, U.S.A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2009
• First Posted: December 15, 2009
• Study Start: June 1, 2007
• Primary Completion: February 1, 2009
• Last Updated: December 29, 2009

Record last verified: 2009-12

Locations

TW (1)