To Identify and Evaluate the Predictive Factors for Depression in Patients Diagnosed With Multiple Sclerosis
Predicting Factors for Depression in Patients With MS in Argentina
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Multiple sclerosis is a chronic, demyelinating disease of the central nervous system and is considered to be one of the most common cause of neurological disability in young adults. The clinical and pathophysiological characteristics of the disease lead to the association of several conditions over time, among which the depression and/or the depression symptoms are one of the most important ones. The underlying mechanism of depression is not clear and the etiology of depression is considered to be multifactorial and especially associated to the psychosocial stress, to the presence of focal demyelinating lesions and to the immune malfunction. Several scales like Beck Depression Inventory Fast Screen (BDI FS), Mini Mental State Examination (MMSE), Hamilton Depression Rating Scale (HDRS) have been used to objectify the presence of depression symptoms in subjects with MS.
OBJECTIVES
Primary objective:
- Identification of the predictive factors for the development of depression symptoms in subjects with MS in Argentina
Secondary objective:
- Evaluation of the proportion of subjects that develop depression symptoms during the follow up
The subjects will be managed with the clinical and therapeutic elements that the treating doctors considered appropriate, without modifying their decisions due to the subjects' inclusion into the study.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Buenos Aires
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Capital Federal, Buenos Aires, Argentinien, 1015
- Instituto de Investigacion Neurológica (Uruguay 840)
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Subjects aged between 18 65 years of both sexes
- Subjects with established MS diagnosis according to the revised Mc Donald criteria - 2005 in any of its clinical forms
- Subjects with signed informed consent
- Subjects wiling to follow the study procedure
Exclusion Criteria:
- Subjects with diagnosis of depression at the moment of the initial evaluation
- Subjects receiving antidepressant drugs at the moment of the initial evaluation
- Subjects with moderate or severe cognitive impairment
- Antecedents of any other psychiatric disease
- Subjects that were receiving or have received any experimental treatment during the 6 months before the inclusion
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Apparition and/or modification of depression symptoms through the agreed assessments
Zeitfenster: Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months)
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The assessments will include Expanded Disability Status Scale, Hamilton Depression Rating Scale, Mini Mental State Examination, Beck Depression Inventory, clock drawing test and findings in magnetic resonance imaging.
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Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Proportion of subjects that developed depression symptoms during the study compared to the total population of subjects enrolled in the study
Zeitfenster: Initial visit (Day 0) to 24 months
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Initial visit (Day 0) to 24 months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Roberto Rey, Neurologist, Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EMR 200077- 500
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