Condition category
Mental and Behavioural Disorders
Date applied
10/08/2016
Date assigned
14/04/2017
Last edited
16/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anxiety disorders are a group of common disorders in which a person experiences overwhelming and often disabling anxiety. They are very common, and symptoms can range from mild to completely debilitating. Panic disorder is a type of anxiety disorder where the sufferers experiences sudden periods of extreme fear with no prior warming, in the form of a severe panic attack. Xenon is a gas approved in the European Union as an anesthetic and used world-wide in imaging. Research has shown however that the use of xenon is not limited and may be infected in treating certain mental health conditions. The aim of this study is to find out whether xenon can be used as an effective treatment for panic disorder.

Who can participate?
Adults who have been diagnosed with panic disorder.

What does the study involve?
All participants undergo between six and seven treatments. This involves administration of a xenon-oxygen mixture via a face mask, which is inhaled by the participant for 2.5-4 minutes. The first three sessions are carried out daily and from session 4 onwards, every other day. At the start of the study, after each treatment and then after 30 to 180 days, participants complete a number of questionnaires to find out whether the number of panic attacks they have had have reduced and to look at the effect on their mental wellbeing.

What are the possible benefits and risks of participating?
There are no notable benefits or risks involved with participating.

Where is the study run from?
Pirogov Russian National Research Medical University (Russia)

When is the study starting and how long is it expected to run for?
February 2016 to January 2016

Who is funding the study?
Nobilis Therapeutics (USA)

Who is the main contact?
Dr Thomas Ichim

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Ichim

ORCID ID

Contact details

Nobilis Therapeutics
9255 Towne Centre Drive
#450
San Diego
92121
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XE001

Study information

Scientific title

Xenon in the treatment of panic disorder: an open-label study

Acronym

Study hypothesis

Administration xenon gas at subanesthetic doses will reduce number of panic attacks in patients with history of panic attack disorder.

Ethics approval

Institutional Review Board of the Pirogov Russian National Research Medical University, 13/01/2014, ref: #57689

Study design

Open-label non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

1. Panic attack disorder
2. Panic attack disorder combined with comorbidity psychiatric conditions

Intervention

All patients undergo administration of a xenon-oxygen mixture via a face mask. Each patient in the study undergoes between 6 and 7 treatments with xenon-oxygen mixture. The first three sessions are carried out daily and from session 4 onwards, every other day.

During the treatments, patients are asked to slowly inhale, holding breath for 5 to 10 seconds, exhale into the loop and after 35-40 seconds exhale outside the contour (to remove CO2) and breathe in the new portion of gas mixture. Xenon inhalation lasts from 2.5 to 4 minutes, and the xenon consumption is capped at 3.0 liters per procedure. The patients are assessed subjectively by the provider, while the vital signs (pulse, blood pressure, oxygen saturation) are continuously monitored. Therapeutic doses used in the mixture of xenon and oxygen in a ratio of xenon to oxygen from 20:80 to 30:70 where the speed of administration is based on the body weight of the patient and baseline spirometry results. As the patients remains fully conscious during the procedure, the administering physician is able to maintain an uninterrupted communication with the patients and to coach them when necessary.

Patients are evaluated after each xenon inhalation and at 30 and 180 days after treatment.

Intervention type

Drug

Phase

Not Applicable

Drug names

Xenon

Primary outcome measures

Number of panic attacks are assessed through self-reporting throughout the study

Secondary outcome measures

1. Anxiety is measured by the “anxiety” subset of the Hospital Anxiety and Depression Scale (HADS_T) at baseline, 30 and 180 days
2. Severity of disease is assessed by Clinical Global Impression Scale Improvement Subscale (CGI-I) at baseline, 30 and 180 days
3. Symptom changes are quantified by the Zung Self-Rating Anxiety Scale (SAS) at baseline, 30 and 180 days
4. Depression is assessed by the “Depression” subset of the Hospital Anxiety and Depression Scale (HADS_T) at baseline, 30 and 180 days

Overall trial start date

11/02/2013

Overall trial end date

14/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of panic disorder (F41.0) according to ICD-10
2. Age 18-75
3. Willing to sign informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Known reactions to xenon therapy
2. Organ failure

Recruitment start date

01/02/2014

Recruitment end date

11/11/2015

Locations

Countries of recruitment

Russian Federation

Trial participating centre

Pirogov Russian National Research Medical University
St. Ostrovityanova 1
Moscow
117997
Russian Federation

Sponsor information

Organisation

Nobilis Therapeutics

Sponsor details

9255 Towne Centre Drive
#450
San Diego
92121
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Nobilis Therapeutics

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/12/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28610592

Publication citations

Additional files

Editorial Notes

16/06/2017: Publication reference added.