Back to resultsN-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
N-methyl glycine
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring obsessive compulsive disorder, sarcosine, glycine transporter I, NMDA receptor
Eligibility 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
Sites / Locations
- China Medical University Hospital
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale
Secondary Outcome Measures
Hamilton Anxiety Rating scale
Full Information
NCT ID
NCT01031927
First Posted
December 13, 2009
Last Updated
December 24, 2009
Sponsor
China Medical University Hospital
Collaborators
Taipei City Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01031927
Brief Title
N-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)
Official Title
Sarcosine as Primary or Adjunctive Therapy in Obsessive Compulsive Disorder: A Prospective, Open-label Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
China Medical University Hospital
Collaborators
Taipei City Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
obsessive compulsive disorder, sarcosine, glycine transporter I, NMDA receptor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
N-methyl glycine
Other Intervention Name(s)
sarcosine
Intervention Description
staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale
Time Frame
week0, 2, 4, 6, 8, and 10
Secondary Outcome Measure Information:
Title
Hamilton Anxiety Rating scale
Time Frame
week0, 2, 4, 6, 8, and 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guochuan E Tsai, MD, PhD
Organizational Affiliation
Department of Psychiatry, Harbor-UCLA Medical Center, California, U.S.A
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
N-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)
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