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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01079975
First received: March 2, 2010
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Factors for Depression in Patients With MS in Argentina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: August 2008
Study Completion Date: July 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with diagnosed MS in Argentinean population.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079975

Locations
Argentina
Instituto de Investigacion Neurológica (Uruguay 840)
Capital Federal, Buenos Aires, Argentina, 1015
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Roberto Rey, Neurologist Instituto de Investigacion Neurológica (Uruguay 840), Capital Federal City, Buenos Aires , 1015 , Argentina
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01079975     History of Changes
Other Study ID Numbers: EMR 200077- 500
Study First Received: March 2, 2010
Last Updated: August 16, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Merck KGaA:
Multiple sclerosis
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Multiple Sclerosis
Sclerosis
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013