Xenon Inhalation for Treatment of Panic Disorder

Nobilis Therapeutics

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Panic Disorder

Treatments: Drug: Placebo; Drug: Xenon

Study type: Interventional

Funder types: Industry

Identifiers

NCT04432155

NBTX-002

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

NBTX-001

Experimental group

Description:

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.

Treatment:

Drug: Xenon

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo