Myasthenia Gravis and Psyche

Myasthenia Gravis Clinical Trial

Official title:

Myasthenia Gravis and Psyche

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205306
• Other study ID #: PsyMG
• Status: Completed
• Start date: May 8, 2017
• Est. completion date: December 14, 2017

Study information

• Verified date: January 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1399
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Myasthenia Gravis

• Age =18 years

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Locations

Country	Name	City	State
Germany	NeuroCure Clinical Research Center (NCRC), Charité	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	directly after inclusion in the study
Secondary	"Häusliche Pflegeskala" (HPS)	questionnaire is used to assess social work Intervention and couple's counselling	directly after inclusion in the study