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

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ClinicalTrials.gov Identifier: NCT03635827
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : March 2, 2020
Sponsor:
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 : July 2020
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
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.
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Responsible Party: Nobilis Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03635827    
Other Study ID Numbers: NBTX-001
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
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
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs