Myasthenia GravisNCT03205306
Myasthenia Gravis and Psyche
An observational study of Myasthenia Gravis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of the study is to systematically capture and characterize mental comorbidities for patients with myasthenia gravis. Anxiety disorders and depression for example, can negatively affect the quality of life and lead to e.g. unemployment and early retirement especially in young patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 1,399 participants
- Where
- 1 siteGermany
- Study dates
- 8 May 2017to 14 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Myasthenia Gravis and their relatives
Who may be able to join
- Patients with Myasthenia Gravis
- Age ≥18 years
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Germany1 site
NeuroCure Clinical Research Center (NCRC), Charité
Berlin, 10117
About this study
The purpose of the study is to systematically capture and characterize mental comorbidities for patients with myasthenia gravis. Anxiety disorders and depression for example, can negatively affect the quality of life and lead to e.g. unemployment and early retirement especially in young patients.
Additionally the researchers want to find out in what way certain aspects of the disease have an influence on the quality of life, and whether different concepts of coping with the disease have different effects on the quality of life for patients with myasthenia gravis.
Read more
During the study, close relatives of patients will also be asked to provide input about their current stress situation in the context of supporting their relative.
Based on the results, the investigators want to improve and supplement established treatment concepts, to ensure a more comprehensive and individual treatment.
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Psyche, Depression, Anxiety Disorder, Posttraumatic Stress Disorder, Disease Processing
- Medical subject headings
- Myasthenia Gravis, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Survey (Patient)
- Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information on diagnosis of mental illness and psychotherapeutic care
- Hospital Anxiety and Depression Scale (HADS - questionnaire for self-completion by patients to determine the levels of anxiety and depression)
- Breslau scale PTBS-7 (questionnaire for self-completion by patients to determine the levels of Probability of posttraumatic stress disorder (PTSD))
- Mya Quality of Life 15 (Mya QoL15 - questionnaire for self-completion by patients for use as a measure of health outcome)
- Freiburg questionnaire for coping (FKV - questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior)
Measured: directly after inclusion in the study
Secondary outcomes (1)
"Häusliche Pflegeskala" (HPS)
questionnaire is used to assess social work Intervention and couple's counselling
Measured: directly after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start8 May 2017
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, Prof. Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205306
- Sponsor's protocol ID
- PsyMG
- Status last verified
- Jan 2023
- First submitted
- 8 Jun 2017
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marbin D, Piper SK, Lehnerer S, Harms U, Meisel A. Mental health in myasthenia gravis patients and its impact on caregiver burden. Sci Rep. 2022 Nov 11;12(1):19275. doi: 10.1038/s41598-022-22078-3.
PubMed 36369246
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myasthenia Gravis and Psyche
- ClinicalTrials.gov ID
- NCT03205306
- Acronym / sponsor ID
- PsyMG
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Psyche, Depression, Anxiety Disorder, Posttraumatic Stress Disorder, Disease Processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,399 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- 8 May 2017 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to systematically capture and characterize mental comorbidities for patients with myasthenia gravis. Anxiety disorders and depression for example, can negatively affect the quality of life and lead to e.g. unemployment and early retirement especially in young patients.
Additionally the researchers want to find out in what way certain aspects of the disease have an influence on the quality of life, and whether different concepts of coping with the disease have different effects on the quality of life for patients with myasthenia gravis.
During the study, close relatives of patients will also be asked to provide input about their current stress situation in the context of supporting their relative.
Based on the results, the investigators want to improve and supplement established treatment concepts, to ensure a more comprehensive and individual treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Myasthenia Gravis and their relatives
Key inclusion criteria (2 listed)
- Patients with Myasthenia Gravis
- Age ≥18 years
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire Survey (Patient)
Time frame: directly after inclusion in the study
* Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information on diagnosis of mental illness and psychotherapeutic care * Hospital Anxiety and Depression Scale (HADS - questionnaire for self-completion by patients to determine the levels of anxiety and depression) * Breslau scale PTBS-7 (questionnaire for self-completion by patients to determine the levels of Probability of posttraumatic stress disorder (PTSD)) * Mya Quality of Life 15 (Mya QoL15 - questionnaire for self-completion by patients for use as a measure of health outcome) * Freiburg questionnaire for coping (FKV - questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior)
1 secondary outcome
"Häusliche Pflegeskala" (HPS)
Time frame: directly after inclusion in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Results publication: PubMed 36369246Marbin D, Piper SK, Lehnerer S, Harms U, Meisel A. Mental health in myasthenia gravis patients and its impact on caregiver burden. Sci Rep. 2022 Nov 11;12(1):19275. doi: 10.1038/s41598-022-22078-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, Prof. Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Survey (Patient) (time frame: directly after inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.