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

NCT01079975 | Completed

• 1 other identifier: EMR 200077- 500
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with diagnosed MS in Argentinean population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Instituto de Investigacion Neurológica (Uruguay 840)

Capital Federal, Buenos Aires, 1015, Argentina

Location

MeSH Terms

Conditions

Multiple Sclerosis; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Roberto Rey, Neurologist

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: July 1, 2012
• Last Updated: July 31, 2014

Record last verified: 2012-08

Locations

AR (1)