ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 20 for:    Recruiting, Not yet recruiting, Available Studies | "Myasthenia Gravis"
Previous Study | Return to List | Next Study

Myasthenia Gravis and Psyche

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03205306
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany

Brief 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.


Condition or disease
Myasthenia Gravis

Study Type : Observational
Estimated Enrollment : 4300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Myasthenia Gravis and Psyche
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. "Häusliche Pflegeskala" (HPS) [ Time Frame: directly after inclusion in the study ]
    questionnaire is used to assess social work Intervention and couple's counselling



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Myasthenia Gravis and their relatives
Criteria

Inclusion Criteria:

  • Patients with Myasthenia Gravis
  • Age ≥18 years

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205306


Contacts
Contact: Andreas Meisel, Prof. Dr. med. +49 30 450 560026 andreas.meisel@charite.de
Contact: Ulrike Harms, Dr. med. ulrike.harms@charite.de

Locations
Germany
NeuroCure Clinical Research Center (NCRC), Charité Recruiting
Berlin, Germany, 10117
Contact: Andreas Meisel, Prof. Dr. med.    +49 30 450 560026    andreas.meisel@charite.de   
Contact: Ulrike Harms, Dr. med.       ulrike.harms@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
Principal Investigator: Andreas Meisel, Prof. Dr. med. Charite University, Berlin, Germany

Responsible Party: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03205306     History of Changes
Other Study ID Numbers: PsyMG
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
Myasthenia Gravis
Psyche
Depression
Anxiety Disorder
Posttraumatic Stress Disorder
Disease Processing

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases