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

NCT02098148 | Withdrawn Phase 2

• 1 other identifier: 2013P001349
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Decrease in Depressive Symptoms

  Baseline to Week 5

Study Arms (2)

Xenon/Placebo

EXPERIMENTAL

Participants in this group will receive three treatments of 25% xenon followed by 3 treatments of placebo (room air).

Drug: Xenon; Drug: Placebo

Placebo/Xenon

EXPERIMENTAL

Participants in this group will receive three treatments of placebo (room air) followed by three treatments of 25% xenon.

Drug: Xenon; Drug: Placebo

Interventions

Xenon DRUG

Placebo/Xenon; Xenon/Placebo

Placebo DRUG

Placebo/Xenon; Xenon/Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Unwillingness or inability to provide written informed consent.
• Lifetime history of schizophrenia or autism spectrum disorder
• 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
• 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.
• 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.
• Female participants with a positive urine pregnancy test at screening
• 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).
• Any screening laboratory abnormality deemed clinically significant by the investigator

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Xenon

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Brian P Brennan, M.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: March 27, 2014
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

US (1)