Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 19, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for people with Major Depressive Disorder (MDD) and Bipolar Depression who have not found relief with traditional medications. The researchers want to see if inhaling a mixture of xenon and oxygen can quickly improve mood and reduce depressive symptoms. The study will involve 20 participants—10 with MDD and 10 with Bipolar Depression—who will receive both the xenon treatment and a control treatment (a nitrogen-oxygen mix) at different times, without knowing which one they are getting.

To be eligible for this trial, participants must be between 18 and 65 years old and diagnosed with MDD or Bipolar Depression. They should have been on a stable medication regimen for at least four weeks and have a moderate level of depressive symptoms. Participants will also need reliable transportation and the support of their psychiatrist. Throughout the study, they can expect close monitoring and to participate in regular visits. This trial aims to provide valuable insights into a potentially effective new treatment for individuals struggling with severe depression.

Gender

ALL

Eligibility 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.

Trial Officials