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

Nobilis Therapeutics Inc.0 sites200 target enrollmentJune 2021

ConditionsPanic Disorder

InterventionsPlacebo Xenon

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Panic Disorder
Sponsor: Nobilis Therapeutics Inc.
Enrollment: 200
Primary Endpoint: PDSS
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2021

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nobilis Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Primary diagnosis of panic disorder according to DSM-
•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.

Arms & Interventions

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.

Intervention: Placebo

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.

Intervention: Xenon