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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079975
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):
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.

Condition or disease
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.


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.

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Study Type : Observational
Actual Enrollment : 301 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with diagnosed MS in Argentinean population.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01079975

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Instituto de Investigacion Neurológica (Uruguay 840)
Capital Federal, Buenos Aires, Argentina, 1015
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
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Principal Investigator: Roberto Rey, Neurologist Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina
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Responsible Party: Merck KGaA, Darmstadt, Germany Identifier: NCT01079975    
Other Study ID Numbers: EMR 200077- 500
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: August 2012
Keywords provided by Merck KGaA, Darmstadt, Germany:
Multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Behavioral Symptoms
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases