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

Predicting Factors for Depression in Patients With MS in Argentina

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis

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.

• Study Type: Observational
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with diagnosed MS in Argentinean population.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apparition and/or modification of depression symptoms through the agreed assessments	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.	Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany
• Investigators: Principal Investigator: Roberto Rey, Neurologist, Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 3, 2010

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 30, 2014
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Depression; Multiple sclerosis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Depression; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: EMR 200077- 500