NCT04432155

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

June 11, 2020

Last Update Submit

March 2, 2021

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (1)

  • PDSS

    Panic Disorder Severity Scale

    Baseline to Week 6

Secondary Outcomes (1)

  • PHQ-9

    Baseline to Week 6

Study Arms (2)

NBTX-001

EXPERIMENTAL

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.

Drug: Xenon

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

XenonDRUG

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

NBTX-001
PlaceboDRUG

30% oxygen, and 70% nitrogen

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of panic disorder according to DSM-5.
  • Male and female patients ≥18 years of age.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Panic Disorder

Interventions

Xenon

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

June 1, 2021

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03