To Identify and Evaluate the Predictive Factors for Depression in Patients Diagnosed With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT01079975
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Apparition and/or modification of depression symptoms through the agreed assessments 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.
- Secondary Outcome Measures
Name Time Method Proportion of subjects that developed depression symptoms during the study compared to the total population of subjects enrolled in the study Initial visit (Day 0) to 24 months
Trial Locations
- Locations (1)
Instituto de Investigacion Neurológica (Uruguay 840)
🇦🇷Capital Federal, Buenos Aires, Argentina