Trial | NCT03635827  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    190
This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with PTSD.
Study Started
Jun 30
2021
Anticipated
Primary Completion
Jun 30
2021
Anticipated
Study Completion
Jul 31
2021
Anticipated
Last Update
Mar 03
2021

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.

Combination Product Placebo

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

NBTX-001 Active Comparator

Placebo Placebo Comparator

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.
No Results Posted