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RECRUITING

NCT03748446

EARLY_PHASE1

Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-12-05

Completion Date

2026-12-01

Last Updated

2025-05-18

Healthy Volunteers

Conditions

Major Depressive Disorder Bipolar Depression

Interventions

DRUG

Xenon

The investigators have chosen to use as a maximum concentration about half the general anesthetic partial pressure of xenon (35%=70%/2) to achieve a dose that is sub-anesthetic. This concentration of xenon is very close to that at which subjects emerging from xenon anesthesia first respond to verbal commands, commonly referred to as MAC awake.

DRUG

Nitrogen gas

nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual

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.

Locations (1)

Dauten Family Center for Bipolar Treatment Innovation

Boston, Massachusetts, United States