Xenon Inhalation for Treatment of Panic Disorder
- Registration Number
- NCT04432155
- Lead Sponsor
- Nobilis Therapeutics Inc.
- Brief Summary
This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with panic disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Primary diagnosis of panic disorder according to DSM-5.
- Male and female patients ≥18 years of age.
Exclusion Criteria
- History of schizophrenia, bipolar and other psychotic disorders.
- Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma, severe lung disease and/or baseline oxygen saturations <92% or any other respiratory conditions / diseases that may affect the respiratory function.
- Currently undergoing targeted empirically-driven psychotherapy for panic disorder or panic disorder-related symptoms.
- Currently undergoing exposure-based psychotherapy for any condition.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NBTX-001 Xenon 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. Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method PDSS Baseline to Week 6 Panic Disorder Severity Scale
- Secondary Outcome Measures
Name Time Method PHQ-9 Baseline to Week 6 Patient Health Questionnaire-9