NCT03635827
Unknown
Phase 2
A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Posttraumatic Stress Disorder
ConditionsPost Traumatic Stress Disorder
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.
Investigators
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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