Adjunctive Glycine for Obsessive Compulsive Disorder | NCT00405535

Studies
Adjunctive Glycine for Obsessive Compulsive Disorder

NCT00405535

Sponsor

Nathan Kline Institute for Psychiatric Research

Status

Completed

Last Update Posted

Dec 16, 2016Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Obsessive Compulsive Disorder

Interventions

glycine
placebo

Countries

United States

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 2016

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 2004

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Nov 28, 2006

First Submission Date that Met QC Criteria

Nov 28, 2006

First Posted Date

Nov 30, 2006Estimated

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 15, 2016

Last Update Posted Date

Dec 16, 2016Estimated

Name	Class
Obsessive Compulsive Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to determine whether individuals with obsessive compulsive disorder who will take a preparation of the amino acid glycine in addition to their current treatment, may experience improvement in their symptoms.

Detailed Description

Individuals with obsessive compulsive disorder (OCD) often find inadequate relief, even with the best of currently available treatments. Some evidence suggests the the neurotransmitter glutamate may be a useful target for new treatments for OCD. The amino acid glycine, if given orally in adequate dosages, can have specific effects on one particular glutamate receptor molecule in the brain, that might be helpful with OC symptoms. This randomized, double-blind protocol will have study participants who suffer with OCD take either a glycine preparation or placebo for 12 weeks. Clinical measures (e.g., Y-BOCS, NIMH-OC) will be recorded at each visit to determine whether those taking the glycine experience clinical benefit.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	glycine powder	Drug: glycine
B	Placebo Comparator	placebo powder	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
glycine	Drug		A
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Y-BOCS (Yale-Brown Obsessive Compulsive Scale)		12 weeks after baseline

Secondary Outcomes

Measure	Description	Time Frame
NIMC-OC scale		12 weeks after baseline
CGI-Improvement		12 weeks after baseline
QLS(Quality of Life Scale)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of OCD present for at least 1 year
Male or female, age 18 to 65
Stable medication regimen for 12 weeks prior to study entry
at least moderately severe OC symptoms

Exclusion Criteria:

Active substance use disorder within the last 6 months
Comorbid schizophrenia, schizoaffective disorder, bipolar disorder, tic disorder, Tourette Disorder, schizotypal personality disorder
Hoarding as the principal OCD symptom
Insulin-dependent diabetes mellitus
Pregnant or breastfeeding

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
William M Greenberg, MD	Nathan Kline Institute for Psychiatric Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Nathan Kline Institute for Psychiatric Research		Orangeburg	New York	10962	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19046587	Derived	Greenberg WM, Benedict MM, Doerfer J, Perrin M, Panek L, Cleveland WL, Javitt DC. Adjunctive glycine in the treatment of obsessive-compulsive disorder in adults. J Psychiatr Res. 2009 Mar;43(6):664-70. doi: 10.1016/j.jpsychires.2008.10.007. Epub 2008 Nov 30.

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

ID	Term
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins