Xenon Inhalation for Treatment of Panic Disorder

NCT ID: NCT04432155

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Conditions

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Xenon

Intervention Type DRUG

30% xenon, 30% oxygen, and 40% nitrogen

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

30% oxygen, and 70% nitrogen

Interventions

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Xenon

30% xenon, 30% oxygen, and 40% nitrogen

Intervention Type DRUG

Placebo

30% oxygen, and 70% nitrogen

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nobilis Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NBTX-002

Identifier Type: -

Identifier Source: org_study_id

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