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To Identify and Evaluate the Predictive Factors for Depression in Patients Diagnosed With Multiple Sclerosis

30. juli 2014 opdateret af: Merck KGaA, Darmstadt, Germany

Predicting Factors for Depression in Patients With MS in Argentina

This is an observational, non controlled, multicentric, prospective study planned to be conducted in 350 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina to identify the predictive factors leading to depression. The incidence of depression symptoms and its influence in the evolution of the disease are unknown in the Argentinean population. Early diagnosis of depression symptoms allows the specific treatment of them and can also delay the rich apparition of the disease. This study intends to quantify the incidence of these symptoms and also aims to evaluate which are the predictive factors of the apparition of the depression.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

301

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1015
        • Instituto de Investigacion Neurológica (Uruguay 840)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects with diagnosed MS in Argentinean population.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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)
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.
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck KGaA, Darmstadt, Germany

Efterforskere

  • Ledende efterforsker: Roberto Rey, Neurologist, Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først indsendt

2. marts 2010

Først indsendt, der opfyldte QC-kriterier

2. marts 2010

Først opslået (Skøn)

3. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2014

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EMR 200077- 500

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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