Depression and Fatigue in MS Patients Treated With Betaferon.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon beta-1b (Betaferon, BAY86-5046) (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Official title: The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis.

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Changes of fatigue score over time

Secondary outcome:

Changes of depression score over time

Treatment adherence

Clinical course of the disease

Overall treatment tolerability as measured by rate of adverse events

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Relapsing-remitting multiple sclerosis

- Age 18+

- Patients initiating Betaferon treatment

Exclusion Criteria:

- Patients previously treated with any immunomodulatory drug

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many Locations, Poland; Recruiting

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Starting date: May 2010
Last updated: November 24, 2011