Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Xenon

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.