To Identify and Evaluate the Predictive Factors for Depression in Patients Diagnosed With Multiple Sclerosis
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Predicting Factors for Depression in Patients With MS in Argentina|
- Apparition and/or modification of depression symptoms through the agreed assessments [ Time Frame: Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months) ] [ Designated as safety issue: No ]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.
- Proportion of subjects that developed depression symptoms during the study compared to the total population of subjects enrolled in the study [ Time Frame: Initial visit (Day 0) to 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
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.
- Identification of the predictive factors for the development of depression symptoms in subjects with MS in Argentina
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079975
|Instituto de Investigacion Neurológica (Uruguay 840)|
|Capital Federal, Buenos Aires, Argentina, 1015|
|Principal Investigator:||Roberto Rey, Neurologist||Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina|