Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

Nobilis Therapeutics

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Post Traumatic Stress Disorder

Treatments: Combination Product: Placebo; Combination Product: NBTX-001 Xenon Inhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT03635827

NBTX-001

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

NBTX-001

Active Comparator group

Treatment:

Combination Product: NBTX-001 Xenon Inhaler

Placebo

Placebo Comparator group

Treatment:

Combination Product: Placebo