Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Who is this study for? Adult patients with major depressive disorder and bipolar disorder
What treatments are being studied? Xenon
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Dauten Family Center for Bipolar Treatment Innovation
RECRUITING
Boston
Contact Information
Primary
Selen Amado, BA
samado2@mgh.harvard.edu
6177267591
Time Frame
Start Date: 2019-12-05
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 20
Treatments
Active_comparator: X-TAU (xenon)
Xenon is a potent antiglutaminergic agent that has been used as an anesthetic with minimal side effects, has neuroprotective effects consistent with antidepressants and has the potential to be a novel antidepressant drug.~\- xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group)
Placebo_comparator: N-TAU (nitrogen-placebo)
Nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group)
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov