Inhalation therapy using xenon for treating major depressive disorder and bipolar disorder
Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder
This study is testing if inhaling a mixture of xenon and oxygen can help people with treatment-resistant major depressive disorder and bipolar depression feel better faster.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03748446 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of inhaled xenon on patients with treatment-resistant major depressive disorder and bipolar depression. It employs a randomized, double-blind crossover design, comparing the impact of xenon-oxygen mixture against a nitrogen-oxygen mixture, both added to standard treatment. The study aims to enroll 20 patients, with equal representation from both conditions, to assess rapid improvements in depressive symptoms. The trial is grounded in recent findings that highlight the role of glutamate dysregulation in depression, positioning xenon as a potential novel antidepressant.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with major depressive disorder or bipolar depression who are currently on stable medication regimens.
Not a fit: Patients with psychotic disorders, schizophrenia, OCD, or primary anxiety disorders are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a rapid and effective treatment option for patients suffering from severe depression who have not responded to traditional antidepressants.
How similar studies have performed: While the use of xenon as an antidepressant is novel, other studies exploring glutamate modulation in depression have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient who meets DSM-V Criteria for MDD or Bipolar Depression (according to DSM-V), as the primary focus of treatment. * Able to understand the risks and benefits of participating in this clinical trial and give informed consent, per judgment of the investigator. * Age greater than or equal to 18 years but less than or equal to 65 years. * Montgomery Asberg Depression Rating Scale ≥20. * On an adequate antidepressant regimen (MDD) or on a mood stabilizing regimen (BP) that is stable for at least four weeks prior to enrollment. * Has reliable adult transportation from and to home. * Has a treating psychiatrist who is in agreement with the patient's participation in the study, and aware of the safety plan in the protocol. * No medical contraindications to receiving a xenon- or a nitrogen-oxygen mixture. * No serious or active pulmonary disease. Exclusion Criteria: * MDD or BP disorder with psychosis, schizophrenia, OCD, or a primary anxiety disorder. * Currently taking a benzodiazepine (including PRN). * Unwilling or unable to comply with study procedures. * Active substance abuse in the past 60 days, diagnosis of substance dependence in the past 12 months, currently active smokers of any substance, including prescription marijuana. * Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception. * Any unstable medical illness (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder). * Any history of brain injury and any active state involving entrapped air/gas within a body cavity with the potential to expand causing organ distension/compression (e.g., bowel obstruction, pneumothorax, or pneumocephalus). * History of hypersensitivity to xenon; history of multiple adverse drug reactions. * Have taken any investigational psychotropic drug within the last 6 months. * Inability to agree to comply with the visit schedule or study procedures. * Not appropriate for participation in a research trial per judgment of the investigator.
Where this trial is running
Boston, Massachusetts
- Dauten Family Center for Bipolar Treatment Innovation — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Nierenberg, MD — Massachussetts General Hospital
- Study coordinator: Selen Amado, BA
- Email: samado2@mgh.harvard.edu
- Phone: 6177267591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.