Obsessive-Compulsive Disorder Clinical Trial
Official title:
A RANDOMIZED PLACEBO-CONTROLLED CROSSOVER TRIAL OF LOW-DOSE XENON FOR THE TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
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 |
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.
Status | Withdrawn |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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital |
United States,
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 |
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