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Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

StatusCompleted
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Final enrollment: 13 participants (planned 20) · Primary completion date changed from estimate of Sep 1, 2026 to Nov 6, 2025 · Eligibility criteria expanded, about 20 words · 1 more Show 4 more changesShow less
    • Final enrollment: 13 participants (planned 20)
    • Primary completion date changed from estimate of Sep 1, 2026 to Nov 6, 2025
    • Eligibility criteria expanded, about 20 words
    • Publications: details revised at 9 of 9 entries
  2. Minor Trial status: Recruiting to Active, Not Recruiting Site details revisedv6 Show 1 more changeShow less
    • Site details revised
  3. Notable Primary completion date: Sep 1, 2024 to Sep 1, 2026 Completion date: Dec 1, 2024 to Dec 1, 2026v5 Show 1 more changeShow less
    • Completion date: Dec 1, 2024 to Dec 1, 2026
  4. Notable Primary completion date: Dec 1, 2023 to Sep 1, 2024v4
  5. Notable Primary completion date: Dec 1, 2022 to Dec 1, 2023v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 15, 2021 to Dec 1, 2022 · Start date changed from estimate of Dec 15, 2018 to Dec 5, 2019 · Study sites: 0 to 1 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Dec 15, 2021 to Dec 1, 2022
    • Start date changed from estimate of Dec 15, 2018 to Dec 5, 2019
    • Study sites: 0 to 1
    • Completion date: Dec 15, 2021 to Dec 1, 2024
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03748446
Lead Sponsor Massachusetts General Hospital
Conditions Major Depressive Disorder, Bipolar Depression
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov