Depression Clinical Trial
— FAMEDOfficial title:
Observational Survey on Fatigue Levels in Relation to Depressive Disorders and Insomnia in Adult Patients With Marfan Syndrome and Ehlers-Danlos Syndrome
NCT number | NCT05712564 |
Other study ID # | FAMED |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 9, 2023 |
Est. completion date | May 9, 2023 |
Verified date | January 2024 |
Source | IRCCS Policlinico S. Donato |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this observational study is to describe and assess the presence of perceived fatigue in subjects with MFS and EDS. the main question it aims to answer through the FSS instrument is: - The relationship of fatigue with physical and psychological characteristics, the presence of depressive disorders and insomnia.
Status | Completed |
Enrollment | 400 |
Est. completion date | May 9, 2023 |
Est. primary completion date | April 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects aged 18 or greater with clinical and/or genetic diagnosis of Marfan syndrome; - Subjects aged 18 or greater with clinical and/or genetic diagnosis of Ehlers-Danlos syndrome; - Signed informed consent. Exclusion Criteria: - Functional physical limitations (handicap, impairment, disability) to activities of daily living; - Clinically significant heart or lung diseases. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Policlinico San Donato | San Donato Milanese | Lombardia |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Donato | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical and psychological features | The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions. | 10 months | |
Secondary | Psychosocial variables | The bivariate correlation analysis will be performed by calculating the Pearson or Spearman correlation coefficient | 10 months |
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