Xenon Inhalation for Treatment of Panic Disorder

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Panic Disorder
• Intervention / Treatment: Drug: Xenon; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NBTX-001; 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.	Drug: Xenon; 30% xenon, 30% oxygen, and 40% nitrogen
Placebo Comparator: 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.	Drug: Placebo; 30% oxygen, and 70% nitrogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PDSS	Panic Disorder Severity Scale	Baseline to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9	Patient Health Questionnaire-9	Baseline to Week 6

Collaborators and Investigators

• Sponsor: Nobilis Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: NBTX-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No