Post Traumatic Stress Disorder
Conditions
Brief summary
This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with PTSD.
Interventions
COMBINATION_PRODUCTNBTX-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.
COMBINATION_PRODUCTPlacebo
The placebo medical gas consists of 30% oxygen and 70% nitrogen.The dose of placebo medical gas is 10 L by volume.
Sponsors
Nobilis Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CAPS-5 | Baseline to Week 6 | Change in CAPS-5 score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCL-5 | Baseline to Week 6 | Change in PCL-5 score |
Outcome results
None listed