Clinical trial assessing xenon therapy for panic attack patients
| ISRCTN | ISRCTN15184285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15184285 |
| Secondary identifying numbers | XE001 |
- Submission date
- 10/08/2016
- Registration date
- 14/04/2017
- Last edited
- 16/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Nobilis Therapeutics
9255 Towne Centre Drive, #450
San Diego
92121
United States of America
Study information
| Study design | Open-label non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Xenon in the treatment of panic disorder: an open-label study |
| Study objectives | Administration xenon gas at subanesthetic doses will reduce number of panic attacks in patients with history of panic attack disorder. |
| Ethics approval(s) | Institutional Review Board of the Pirogov Russian National Research Medical University, 13/01/2014, ref: #57689 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Xenon |
| Primary outcome measure | 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 study start date | 11/02/2013 |
| Completion date | 14/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | 1. Diagnosis of panic disorder (F41.0) according to ICD-10 2. Age 18-75 3. Willing to sign informed consent |
| Key exclusion criteria | 1. Known reactions to xenon therapy 2. Organ failure |
| Date of first enrolment | 01/02/2014 |
| Date of final enrolment | 11/11/2015 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Moscow
117997
Russian Federation
Sponsor information
Industry
9255 Towne Centre Drive, #450
San Diego
92121
United States of America
"ROR" |
https://ror.org/03wfcm341 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/06/2017 | Yes | No |
Editorial Notes
16/06/2017: Publication reference added.
