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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Investigacion Neurológica (Uruguay 840)

Capital Federal, Buenos Aires, 1015, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

Predicting Factors for Depression in Patients With MS in Argentina

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2012
First posted: Mar 3, 2010
Registry last updated: Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed