Back to resultsXenon Inhalation for Treatment of Panic Disorder
Primary Purpose
Panic Disorder
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Xenon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NBTX-001
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
PDSS
Panic Disorder Severity Scale
Secondary Outcome Measures
PHQ-9
Patient Health Questionnaire-9
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04432155
Brief Title
Xenon Inhalation for Treatment of Panic Disorder
Official Title
A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobilis Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with panic disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NBTX-001
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Xenon
Intervention Description
30% xenon, 30% oxygen, and 40% nitrogen
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
30% oxygen, and 70% nitrogen
Primary Outcome Measure Information:
Title
PDSS
Description
Panic Disorder Severity Scale
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
PHQ-9
Description
Patient Health Questionnaire-9
Time Frame
Baseline to Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Xenon Inhalation for Treatment of Panic Disorder
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