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Adjunctive Glycine for Obsessive Compulsive Disorder

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
glycine
placebo
Sponsored by
Nathan Kline Institute for Psychiatric Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring OCD, Obsessive Compulsive Disorder, Glycine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Nathan Kline Institute for Psychiatric Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

glycine powder

placebo powder

Outcomes

Primary Outcome Measures

Y-BOCS (Yale-Brown Obsessive Compulsive Scale)

Secondary Outcome Measures

NIMC-OC scale
CGI-Improvement
QLS(Quality of Life Scale)
Sheehan Disability Scale

Full Information

First Posted
November 28, 2006
Last Updated
December 15, 2016
Sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
Obsessive Compulsive Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00405535
Brief Title
Adjunctive Glycine for Obsessive Compulsive Disorder
Official Title
Adjunctive Glycine for Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
Obsessive Compulsive Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
OCD, Obsessive Compulsive Disorder, Glycine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
glycine powder
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
placebo powder
Intervention Type
Drug
Intervention Name(s)
glycine
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Y-BOCS (Yale-Brown Obsessive Compulsive Scale)
Time Frame
12 weeks after baseline
Secondary Outcome Measure Information:
Title
NIMC-OC scale
Time Frame
12 weeks after baseline
Title
CGI-Improvement
Time Frame
12 weeks after baseline
Title
QLS(Quality of Life Scale)
Time Frame
12 weeks after baseline
Title
Sheehan Disability Scale
Time Frame
12 weeks after baseline

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William M Greenberg, MD
Organizational Affiliation
Nathan Kline Institute for Psychiatric Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Nathan Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19046587
Citation
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.
Results Reference
derived

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Adjunctive Glycine for Obsessive Compulsive Disorder

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