Depression and Fatigue in MS Patients Treated With Betaferon.

Completed

• Conditions: Multiple Sclerosis
• Interventions: Biological: Interferon beta-1b (Betaferon, BAY86-5046)

• Registration Number: NCT01354665
• Lead Sponsor: Bayer

Brief Summary

This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations.

The study is conducted in routine practice setting hence no interference with standard care takes place.

Pharmacologic treatments of MS-fatigue and depression will also be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 567

Inclusion Criteria

• Relapsing-remitting multiple sclerosis
• Age 18+
• Patients initiating Betaferon treatment

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Exclusion Criteria

• Patients previously treated with any immunomodulatory drug

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta-1b (Betaferon, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
Changes of fatigue score over time	short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline

Secondary Outcome Measures

Name	Time	Method
Changes of depression score over time	short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
Treatment adherence	12 months
Clinical course of the disease	12 months
Overall treatment tolerability as measured by rate of adverse events	12 months