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NCT04432155 Clinical Trial

Xenon Inhalation for Treatment of Panic Disorder

Panic Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04432155
Other study ID # NBTX-002
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2021
Est. completion date December 2021

Study information
Verified date March 2021
Source Nobilis Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date December 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Xenon
30% xenon, 30% oxygen, and 40% nitrogen
• Placebo
30% oxygen, and 70% nitrogen

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nobilis Therapeutics Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary PDSS Panic Disorder Severity Scale Baseline to Week 6
Secondary PHQ-9 Patient Health Questionnaire-9 Baseline to Week 6
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