Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

NCT ID: NCT03635827

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

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-07-31

Brief Summary

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

Detailed Description

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Conditions

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Post Traumatic Stress 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

Group Type ACTIVE_COMPARATOR

NBTX-001 Xenon Inhaler

Intervention Type COMBINATION_PRODUCT

The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

The placebo medical gas consists of 30% oxygen and 70% nitrogen.The dose of placebo medical gas is 10 L by volume.

Interventions

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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 Type 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 COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \[DSM-5\] criteria and a Clinician Administered PTSD Scale \[CAPS-5\] total severity score of \>30).
* Male and female patients between the ages of 18 and 85 years.

Exclusion Criteria

* History of schizophrenia, bipolar and other psychotic disorders.
* Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function.
* Currently undergoing PTSD-targeted psychotherapy.
* Currently undergoing exposure-based psychotherapy for any condition.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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-001

Identifier Type: -

Identifier Source: org_study_id

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