Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Sponsored by Massachusetts General Hospital

About this trial

Last updated a year ago

Study ID

2018P002500

Status

Recruiting

Type

Interventional

Phase

Early Phase 1

Placebo

Accepting

18 to 65 Years

All Sexes

Trial Timing

Started 6 years ago

What is this trial 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.

What are the participation requirements?

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.