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Adjunctive Glycine for Obsessive Compulsive Disorder

This study has been completed.
Sponsor:
Collaborator:
Obsessive Compulsive Foundation
Information provided by:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00405535
First received: November 28, 2006
Last updated: August 21, 2007
Last verified: August 2007
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Glycine for Obsessive Compulsive Disorder

Resource links provided by NLM:

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
Experimental: A
glycine powder
 Dietary Supplement: glycine
Placebo Comparator: B
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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00405535     History of Changes
Other Study ID Numbers: 04I/C06
Study First Received: November 28, 2006
Last Updated: August 21, 2007
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

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Glycine
Glycine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013