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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02098148
• Other study ID #: 2013P001349
• Status: Withdrawn
• Phase: Phase 2
• First received: January 10, 2014
• Last updated: March 24, 2014
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Xenon

• Placebo

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No