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Trial record 1 of 1 for:    NCT03635827
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Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03635827
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : March 3, 2021
Information provided by (Responsible Party):
Nobilis Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Combination Product: NBTX-001 Xenon Inhaler Combination Product: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Posttraumatic Stress Disorder
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Arm Intervention/treatment
Active Comparator: NBTX-001 Combination Product: NBTX-001 Xenon Inhaler
The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.

Placebo Comparator: Placebo Combination Product: Placebo
The placebo medical gas consists of 30% oxygen and 70% nitrogen.The dose of placebo medical gas is 10 L by volume.

Primary Outcome Measures :
  1. CAPS-5 [ Time Frame: Baseline to Week 6 ]
    Change in CAPS-5 score

Secondary Outcome Measures :
  1. PCL-5 [ Time Frame: Baseline to Week 6 ]
    Change in PCL-5 score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Responsible Party: Nobilis Therapeutics Inc. Identifier: NCT03635827    
Other Study ID Numbers: NBTX-001
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs