Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

Phase 2

• Conditions: Post Traumatic Stress Disorder
• Interventions: Combination Product: NBTX-001 Xenon Inhaler; Combination Product: Placebo

• Registration Number: NCT03635827
• Lead Sponsor: Nobilis Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03
• Study Start: 2021-06
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBTX-001	NBTX-001 Xenon Inhaler	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
CAPS-5	Baseline to Week 6	Change in CAPS-5 score

Secondary Outcome Measures

Name	Time	Method
PCL-5	Baseline to Week 6	Change in PCL-5 score