Adjunctive Glycine for Obsessive Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:

Adjunctive Glycine for Obsessive Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405535
• Other study ID #: 04I/C06
• Status: Completed
• Phase: N/A
• First received: November 28, 2006
• Last updated: December 15, 2016
• Start date: June 2004
• Est. completion date: December 2006

Study information

• Verified date: December 2016
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• glycine

Other:
• placebo

Locations

Country	Name	City	State
United States	The Nathan Kline Institute for Psychiatric Research	Orangeburg	New York

Sponsors (2)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research	Obsessive Compulsive Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Y-BOCS (Yale-Brown Obsessive Compulsive Scale)		12 weeks after baseline
Secondary	NIMC-OC scale		12 weeks after baseline
Secondary	CGI-Improvement		12 weeks after baseline
Secondary	QLS(Quality of Life Scale)		12 weeks after baseline
Secondary	Sheehan Disability Scale		12 weeks after baseline