To Identify and Evaluate the Predictive Factors for Depression in Patients Diagnosed With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01079975|
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : July 31, 2014
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||301 participants|
|Official Title:||Predicting Factors for Depression in Patients With MS in Argentina|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||July 2012|
- 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) ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|