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NCT03635827 Clinical Trial

Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03635827
Other study ID # NBTX-001
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2021
Est. completion date July 2021

Study information
Verified date March 2021
Source Nobilis Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 190
Est. completion date July 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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
The placebo medical gas consists of 30% oxygen and 70% nitrogen.The dose of placebo medical gas is 10 L by volume.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nobilis Therapeutics Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary CAPS-5 Change in CAPS-5 score Baseline to Week 6
Secondary PCL-5 Change in PCL-5 score Baseline to Week 6
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