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Clinical Trials/NCT03635827
NCT03635827
Unknown
Phase 2

A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Posttraumatic Stress Disorder

Nobilis Therapeutics Inc.0 sites190 target enrollmentJune 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
Nobilis Therapeutics Inc.
Enrollment
190
Primary Endpoint
CAPS-5
Last Updated
5 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2021
End Date
July 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

CAPS-5

Time Frame: Baseline to Week 6

Change in CAPS-5 score

Secondary Outcomes

  • PCL-5(Baseline to Week 6)

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