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Trial record 48 of 2701 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT03748446
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Bipolar Depression Drug: Xenon Drug: Nitrogen gas Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A randomized, double-blind crossover model 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The identity of the inhalant will be blinded to all except the anesthesiologist, who will not participate in any assessment of the depressive symptoms.
Primary Purpose: Treatment
Official Title: Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Xenon

Arm Intervention/treatment
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)

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.

Placebo Comparator: N-TAU (nitrogen-placebo)
Nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group)
Drug: Nitrogen gas
nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual




Primary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: Improvement at day 1 ]

    Hamilton Depression Rating Scale (HDRS):This scale is a 6-item survey which is one of the most frequently used instruments for evaluating depression in adults, the questionnaire allows clinicians to assess the nature and severity of mood disorders in patient populations.

    Score Range: 0-42, higher scores means worse outcomes


  2. Depressive Symptoms [ Time Frame: Improvement at day 1 ]

    Quick Inventory of Depressive Symptomatology-Clinician Version (QIDS-C): The Quick Inventory of Depressive Symptomatology (QIDS) is designed to assess the severity of depressive symptoms. The questions to be administered by the clinician assess the severity of the nine diagnostic symptom criteria used in DSM.

    Score Range: 0-48, higher scores means worse outcomes




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748446


Contacts
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Contact: Selen Amado, BA 6177267591 samado2@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Andrew Nierenberg, MD Massachussetts General Hospital

Publications:

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Responsible Party: Andrew A. Nierenberg, MD, Principle Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03748446     History of Changes
Other Study ID Numbers: 2018P002500
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Disease
Bipolar Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs