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

NCT ID: NCT01079975

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 301 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-07-31

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Rey, Neurologist

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Instituto de Investigacion Neurológica (Uruguay 840)

Capital Federal, Buenos Aires, Argentina

Countries

Argentina

Other Identifiers

EMR 200077- 500

Identifier Type: -

Identifier Source: org_study_id