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

This study has been completed.

Sponsor:

Collaborator:

Taipei City Hospital

Information provided by:

China Medical University Hospital

ClinicalTrials.gov Identifier:

NCT01031927

First received: December 13, 2009

Last updated: December 24, 2009

Last verified: December 2009

History of Changes

Purpose

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	Intervention	Phase
Obsessive Compulsive Disorder	Drug: N-methyl glycine	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sarcosine as Primary or Adjunctive Therapy in Obsessive Compulsive Disorder: A Prospective, Open-label Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

Drug Information available for: Glycine

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:

Yale-Brown Obsessive Compulsive Scale [ Time Frame: week0, 2, 4, 6, 8, and 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hamilton Anxiety Rating scale [ Time Frame: week0, 2, 4, 6, 8, and 10 ] [ Designated as safety issue: No ]


Estimated Enrollment:	30
Study Start Date:	June 2007
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: sarcosine

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031927

Locations


Taiwan
China Medical University Hospital
Taichung, Taiwan

Sponsors and Collaborators

China Medical University Hospital

Taipei City Hospital

Investigators


Study Chair:	Guochuan E Tsai, MD, PhD	Department of Psychiatry, Harbor-UCLA Medical Center, California, U.S.A

More Information

No publications provided


Responsible Party:	Po-Lun Wu, China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT01031927 History of Changes
Other Study ID Numbers:	DMR96-IRB-75
Study First Received:	December 13, 2009
Last Updated:	December 24, 2009
Health Authority:	Taiwan: Department of Health

Keywords provided by China Medical University Hospital:


obsessive compulsive disorder sarcosine glycine transporter I NMDA receptor

Additional relevant MeSH terms:


Compulsive Personality Disorder Disease Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Pathologic Processes Personality Disorders	Glycine Glycine Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015

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