Trial of Low-Dose Xenon For The Treatment Of Obsessive-Compulsive Disorder

A RANDOMIZED PLACEBO-CONTROLLED CROSSOVER TRIAL OF LOW-DOSE XENON FOR THE TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER

The primary purpose of this study is to investigate whether administration of xenon reduces symptoms of Obsessive-Compulsive Disorder (OCD). Xenon is a naturally occurring gas that has been used in clinical settings both as a general anesthetic agent and as a contrast agent for computed tomography (CT) scans. Investigators believe that xenon may be effective in reducing symptoms of OCD due to its ability to reduce the activity of a specific brain chemical called glutamate, which has been shown to be abnormal in the brains of people with OCD.

It is important to understand that this study uses a placebo, or inactive, treatment. In this study, the placebo treatment is inhalation of room air (instead of xenon). All participants will receive both xenon and placebo treatments at some point over the course of the study. However, neither the participants nor the study investigators will know which treatment you are receiving.

Study Overview

• Status: Withdrawn
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Xenon

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female age ≥ 18 and ≤ 55
2. Meets DSM-IV criteria for OCD as primary presenting disorder
3. Score of ≥ 18 on the Y-BOCS at screening (Visit 1).

Exclusion Criteria:

1. Unwillingness or inability to provide written informed consent.
2. Lifetime history of schizophrenia or autism spectrum disorder
3. Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening
4. Clinically significant medical disease including, but not limited to, pulmonary, cardiac (including uncontrolled hypertension), hepatic, renal, or endocrine disorders, which would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator.
5. Clinically significant neurologic disease including, but not limited to, seizure disorder, neurodegenerative diseases, and history of traumatic brain injury that would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator.
6. Female participants with a positive urine pregnancy test at screening
7. Pregnancy. Females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, double-barrier method, male partner sterilization).
8. Any screening laboratory abnormality deemed clinically significant by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xenon/Placebo; Participants in this group will receive three treatments of 25% xenon followed by 3 treatments of placebo (room air).	Drug: Placebo; Drug: Xenon
Experimental: Placebo/Xenon; Participants in this group will receive three treatments of placebo (room air) followed by three treatments of 25% xenon.	Drug: Placebo; Drug: Xenon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in OCD Symptoms	Xenon is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of three treatments when compared to placebo (room air).	Baseline to Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Depressive Symptoms	Xenon is associated with a decrease in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at completion of three treatments when compared to placebo.	Baseline to Week 5

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Investigators: Principal Investigator: Brian P Brennan, M.D., McLean Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 24, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: 2013P001349