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Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

Primary Purpose

Post Traumatic Stress Disorder

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NBTX-001 Xenon Inhaler
Placebo
Sponsored by
Nobilis Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria and a Clinician Administered PTSD Scale [CAPS-5] total severity score of >30).
  • Male and female patients between the ages of 18 and 85 years.

Exclusion Criteria:

  • History of schizophrenia, bipolar and other psychotic disorders.
  • Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function.
  • Currently undergoing PTSD-targeted psychotherapy.
  • Currently undergoing exposure-based psychotherapy for any condition.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    NBTX-001

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    CAPS-5
    Change in CAPS-5 score

    Secondary Outcome Measures

    PCL-5
    Change in PCL-5 score

    Full Information

    First Posted
    August 15, 2018
    Last Updated
    March 2, 2021
    Sponsor
    Nobilis Therapeutics Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03635827
    Brief Title
    Xenon Inhalation for Treatment of Posttraumatic Stress Disorder
    Official Title
    A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Posttraumatic Stress Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nobilis Therapeutics Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with PTSD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    190 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NBTX-001
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Combination Product
    Intervention Name(s)
    NBTX-001 Xenon Inhaler
    Intervention Description
    The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Placebo
    Intervention Description
    The placebo medical gas consists of 30% oxygen and 70% nitrogen.The dose of placebo medical gas is 10 L by volume.
    Primary Outcome Measure Information:
    Title
    CAPS-5
    Description
    Change in CAPS-5 score
    Time Frame
    Baseline to Week 6
    Secondary Outcome Measure Information:
    Title
    PCL-5
    Description
    Change in PCL-5 score
    Time Frame
    Baseline to Week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria and a Clinician Administered PTSD Scale [CAPS-5] total severity score of >30). Male and female patients between the ages of 18 and 85 years. Exclusion Criteria: History of schizophrenia, bipolar and other psychotic disorders. Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function. Currently undergoing PTSD-targeted psychotherapy. Currently undergoing exposure-based psychotherapy for any condition.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

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