Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

Phase 3UnknownNCT03635827

Nobilis Therapeutics Inc.190 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

190

Conditions

Post Traumatic Stress Disorder

Interventions

NBTX-001 Xenon InhalerCOMBINATION_PRODUCT

The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.

PlaceboCOMBINATION_PRODUCT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Change in CAPS-5 score

Time frame: Baseline to Week 6

Secondary Outcomes

PCL-5

Change in PCL-5 score

Time frame: Baseline to Week 6

Data from ClinicalTrials.gov

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