Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-29 @ 5:42 AM
Study NCT ID:
NCT03205306
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2017-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myasthenia Gravis and Psyche
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1399}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2017-06-08', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire Survey (Patient)', 'timeFrame': 'directly after inclusion in the study', 'description': '* Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information on diagnosis of mental illness and psychotherapeutic care\n* Hospital Anxiety and Depression Scale (HADS - questionnaire for self-completion by patients to determine the levels of anxiety and depression)\n* Breslau scale PTBS-7 (questionnaire for self-completion by patients to determine the levels of Probability of posttraumatic stress disorder (PTSD))\n* Mya Quality of Life 15 (Mya QoL15 - questionnaire for self-completion by patients for use as a measure of health outcome)\n* Freiburg questionnaire for coping (FKV - questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior)'}], 'secondaryOutcomes': [{'measure': '"Häusliche Pflegeskala" (HPS)', 'timeFrame': 'directly after inclusion in the study', 'description': "questionnaire is used to assess social work Intervention and couple's counselling"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'Psyche', 'Depression', 'Anxiety Disorder', 'Posttraumatic Stress Disorder', 'Disease Processing'], 'conditions': ['Myasthenia Gravis']}, 'referencesModule': {'references': [{'pmid': '36369246', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAdditionally 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.\n\nDuring 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.\n\nBased on the results, the investigators want to improve and supplement established treatment concepts, to ensure a more comprehensive and individual treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Myasthenia Gravis and their relatives', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Myasthenia Gravis\n* Age ≥18 years\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT03205306', 'briefTitle': 'Myasthenia Gravis and Psyche', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Myasthenia Gravis and Psyche', 'orgStudyIdInfo': {'id': 'PsyMG'}}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'NeuroCure Clinical Research Center (NCRC), Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Meisel, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeuroCure Clinical Research Center, Charite, Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Andreas Meisel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}