Adjunctive Glycine for Obsessive Compulsive Disorder

Study Overview
=================
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.

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.

Official Title
-----------------
Adjunctive Glycine for Obsessive Compulsive Disorder

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: glycine
* Other: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>glycine powder | Drug: glycine<br> <br> |
| Placebo Comparator: B<br>placebo powder | Other: placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycine, OCD, Obsessive Compulsive Disorder