N-methyl Glycine (Sarcosine) for the Treatment of Obsessi... | NCT01031927

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

NCT01031927

Sponsor

China Medical University Hospital

Status

Completed

Last Update Posted

Dec 29, 2009Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Obsessive Compulsive Disorder

Interventions

N-methyl glycine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Not provided

First Submitted Date

Dec 13, 2009

First Submission Date that Met QC Criteria

Dec 14, 2009

First Posted Date

Dec 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2009

Last Update Posted Date

Dec 29, 2009Estimated

Name	Class
Taipei City Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-methyl glycine	Drug	staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day		sarcosine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Yale-Brown Obsessive Compulsive Scale		week0, 2, 4, 6, 8, and 10

Secondary Outcomes

Measure	Description	Time Frame
Hamilton Anxiety Rating scale		week0, 2, 4, 6, 8, and 10

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital		Taichung			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012521	Sarcosine

Ancestor Terms

ID	Term
D034442	N-substituted Glycines
D005998	Glycine
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided