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CompletedNCT03205306Updated Jan 10, 2023

Myasthenia Gravis and Psyche

An observational study in Myasthenia Gravis, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-10.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,399
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Myasthenia Gravis

Keywords

  • Myasthenia Gravis
  • Psyche
  • Depression
  • Anxiety Disorder
  • Posttraumatic Stress Disorder
  • Disease Processing
03

In context

Myasthenia Gravis

324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.

This study's enrollment of 1,399 is above the median of 140 across 104 observational studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with Myasthenia Gravis and their relatives

Inclusion criteria

  • Patients with Myasthenia Gravis
  • Age ≥18 years

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,399 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: directly after inclusion in the study

Secondary outcomes

  1. "Häusliche Pflegeskala" (HPS)

    questionnaire is used to assess social work Intervention and couple's counselling

    Time frame: directly after inclusion in the study

07

Study locations

1 site
  • NeuroCure Clinical Research Center (NCRC), Charité
    Berlin, 10117, Germany
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03205306
Lead sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin
Responsible party
Andreas Meisel (Prof. Dr. med., Charite University, Berlin, Germany) — Principal investigator
First posted
Jul 2, 2017
Start date
May 8, 2017
Primary completion
Dec 14, 2017
Completion
Dec 14, 2017
Last update
Jan 10, 2023

Study contacts

Andreas Meisel, Prof. Dr. med.
principal investigator · Charite University, Berlin, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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