Back to resultsTrial of Low-Dose Xenon For The Treatment Of Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Xenon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Xenon/Placebo
Placebo/Xenon
Arm Description
Participants in this group will receive three treatments of 25% xenon followed by 3 treatments of placebo (room air).
Participants in this group will receive three treatments of placebo (room air) followed by three treatments of 25% xenon.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02098148
Brief Title
Trial of Low-Dose Xenon For The Treatment Of Obsessive-Compulsive Disorder
Official Title
A RANDOMIZED PLACEBO-CONTROLLED CROSSOVER TRIAL OF LOW-DOSE XENON FOR THE TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn. Unable to set up appropriate infrastructure to support study.
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xenon/Placebo
Arm Type
Experimental
Arm Description
Participants in this group will receive three treatments of 25% xenon followed by 3 treatments of placebo (room air).
Arm Title
Placebo/Xenon
Arm Type
Experimental
Arm Description
Participants in this group will receive three treatments of placebo (room air) followed by three treatments of 25% xenon.
Intervention Type
Drug
Intervention Name(s)
Xenon
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Decrease in OCD Symptoms
Description
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).
Time Frame
Baseline to Week 5
Secondary Outcome Measure Information:
Title
Decrease in Depressive Symptoms
Description
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.
Time Frame
Baseline to Week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian P Brennan, M.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Low-Dose Xenon For The Treatment Of Obsessive-Compulsive Disorder
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