Xenon Inhalation for Treatment of Panic Disorder

Phase 2

• Conditions: Panic Disorder
• Interventions: Drug: Xenon; Drug: Placebo

• 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

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03
• Study Start: 2021-06
• Primary Completion: 2021-11
• Study Completion: 2021-12

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