Adjunctive Glycine for Obsessive Compulsive Disorder - Full Text View

Sponsors and Collaborators:	Nathan Kline Institute for Psychiatric Research Obsessive Compulsive Foundation
Information provided by:	Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:	NCT00405535

Purpose

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.

Condition	Intervention
Obsessive Compulsive Disorder	Dietary Supplement: glycine Other: placebo powder

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Adjunctive Glycine for Obsessive Compulsive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Glycine

U.S. FDA Resources

Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:

Y-BOCS (Yale-Brown Obsessive Compulsive Scale) [ Time Frame: 12 weeks after baseline ]

Secondary Outcome Measures:

NIMC-OC scale [ Time Frame: 12 weeks after baseline ]
CGI-Improvement [ Time Frame: 12 weeks after baseline ]
QLS(Quality of Life Scale) [ Time Frame: 12 weeks after baseline ]
Sheehan Disability Scale [ Time Frame: 12 weeks after baseline ]

Enrollment:	24
Study Start Date:	June 2004
Study Completion Date:	December 2006

Arms	Assigned Interventions
A: Experimental glycine powder	Dietary Supplement: glycine
B: Placebo Comparator placebo powder	Other: placebo powder

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405535

Locations

United States, New York
The Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962

Sponsors and Collaborators

Nathan Kline Institute for Psychiatric Research

Obsessive Compulsive Foundation

Investigators

Principal Investigator:

William M Greenberg, MD

Nathan Kline Institute for Psychiatric Research

More Information

No publications provided by Nathan Kline Institute for Psychiatric Research

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Nov 30.

Study ID Numbers:	04I/C06
Study First Received:	November 28, 2006
Last Updated:	August 21, 2007
ClinicalTrials.gov Identifier:	NCT00405535 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Nathan Kline Institute for Psychiatric Research:

OCD
Obsessive Compulsive Disorder
Glycine

Study placed in the following topic categories:

Neurotransmitter Agents
Anxiety Disorders
Glycine
Mental Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Anxiety Disorders
Glycine

Mental Disorders
Physiological Effects of Drugs
Glycine Agents
Pharmacologic Actions
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on September 03, 2009