Actively Recruiting
Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder
Led by Massachusetts General Hospital · Updated on 2025-05-18
20
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators will test the hypothesis that inhaled xenon will produce a rapid improvement in depressive symptoms in patients suffering from treatment-resistant depression. Specifically, the investigators will conduct a parallel randomized, double-blind crossover study that will compare the effects of xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group) to the effects of nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group). A total of 20 severely depressed patients, 10 with major depressive disorder (MDD) and 10 with Bipolar Depression (BP), will be exposed in random order to N-TAU and X-TAU in a double-blind protocol.
CONDITIONS
Official Title
Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who meets DSM-V Criteria for MDD or Bipolar Depression as primary treatment focus
- Able to understand risks and benefits and give informed consent
- Age 18 to 65 years
- Montgomery Asberg Depression Rating Scale score of 20 or higher
- On stable antidepressant (MDD) or mood stabilizing (BP) regimen for at least 4 weeks
- Has reliable adult transportation to and from home
- Treating psychiatrist agrees with participation and safety plan
- No medical contraindications to xenon or nitrogen-oxygen mixtures
- No serious or active pulmonary disease
You will not qualify if you...
- MDD or BP with psychosis, schizophrenia, OCD, or primary anxiety disorder
- Currently taking benzodiazepines (including PRN)
- Unwilling or unable to follow study procedures
- Active substance abuse in past 60 days or dependence in past 12 months
- Current smokers of any substance including prescription marijuana
- Pregnant or women of childbearing potential not using accepted contraception
- Any unstable medical illness affecting cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological systems or uncontrolled seizures
- History of brain injury or active trapped air/gas conditions (e.g., bowel obstruction, pneumothorax, pneumocephalus)
- History of hypersensitivity to xenon or multiple adverse drug reactions
- Use of investigational psychotropic drugs in last 6 months
- Inability to comply with visit schedule or study procedures
- Considered inappropriate for research participation by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dauten Family Center for Bipolar Treatment Innovation
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Selen Amado, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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