Depression and Fatigue in MS Patients Treated With Betaferon. (FADO)
|ClinicalTrials.gov Identifier: NCT01354665|
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : January 21, 2015
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.
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Biological: Interferon beta-1b (Betaferon, BAY86-5046)|
|Study Type :||Observational|
|Actual Enrollment :||567 participants|
|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 Start Date :||May 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Biological: Interferon beta-1b (Betaferon, BAY86-5046)
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.
- Changes of fatigue score over time [ Time Frame: short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline ]
- Changes of depression score over time [ Time Frame: 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 [ Time Frame: 12 months ]
- Clinical course of the disease [ Time Frame: 12 months ]
- Overall treatment tolerability as measured by rate of adverse events [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354665
|Many Locations, Poland|
|Study Director:||Bayer Study Director||Bayer|