- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, 1015
- Instituto de Investigacion Neurológica (Uruguay 840)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Apparition and/or modification of depression symptoms through the agreed assessments
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Proportion of subjects that developed depression symptoms during the study compared to the total population of subjects enrolled in the study
Tidsramme: Initial visit (Day 0) to 24 months
|
Initial visit (Day 0) to 24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Roberto Rey, Neurologist, Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EMR 200077- 500
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