Adjunctive Glycine for Obsessive Compulsive Disorder

December 15, 2016 updated by: Nathan Kline Institute for Psychiatric Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
glycine powder
Drug: glycine
Placebo Comparator: B
placebo powder
Other: placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nathan Kline Institute for Psychiatric Research

Collaborators

Obsessive Compulsive Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04I/C06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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