RECRUITING

Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Conditions

Major Depressive Disorder Bipolar Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Quick Facts

Study Start:2019-12-05

Study Completion:2024-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03748446

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Selen Amado, BA

CONTACT

6177267591

samado2@mgh.harvard.edu

Principal Investigator

Andrew Nierenberg, MD

PRINCIPAL_INVESTIGATOR

Massachussetts General Hospital

Study Locations (Sites)

Dauten Family Center for Bipolar Treatment Innovation

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Andrew Nierenberg, MD, PRINCIPAL_INVESTIGATOR, Massachussetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-05

Study Completion Date2024-12-01

Study Record Updates

Study Start Date2019-12-05

Study Completion Date2024-12-01

Terms related to this study

Additional Relevant MeSH Terms

Major Depressive Disorder
Bipolar Depression