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- Klinische proef NCT01079975
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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Buenos Aires
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Capital Federal, Buenos Aires, Argentinië, 1015
- Instituto de Investigacion Neurológica (Uruguay 840)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Apparition and/or modification of depression symptoms through the agreed assessments
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Proportion of subjects that developed depression symptoms during the study compared to the total population of subjects enrolled in the study
Tijdsspanne: Initial visit (Day 0) to 24 months
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Initial visit (Day 0) to 24 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Roberto Rey, Neurologist, Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EMR 200077- 500
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