NCT00405535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

First QC Date

November 28, 2006

Last Update Submit

December 15, 2016

Conditions

Obsessive Compulsive Disorder

Keywords

OCDObsessive Compulsive DisorderGlycine

Outcome Measures

Primary Outcomes (1)

  • Y-BOCS (Yale-Brown Obsessive Compulsive Scale)

    12 weeks after baseline

Secondary Outcomes (4)

  • NIMC-OC scale

    12 weeks after baseline

  • CGI-Improvement

    12 weeks after baseline

  • QLS(Quality of Life Scale)

    12 weeks after baseline

  • Sheehan Disability Scale

    12 weeks after baseline

Study Arms (2)

A

EXPERIMENTAL

glycine powder

Drug: glycine

B

PLACEBO COMPARATOR

placebo powder

Other: placebo

Interventions

glycineDRUG
A
placeboOTHER
B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

  • 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.

    PMID: 19046587DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Glycine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • William M Greenberg, MD

    Nathan Kline Institute for Psychiatric Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

June 1, 2004

Study Completion

December 1, 2006

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

US(1)