Depression and Fatigue in MS Patients Treated With Betaferon.

Multiple Sclerosis Clinical Trial

— FADO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354665
• Other study ID #: 15307
• Secondary ID: BF1012PL
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: January 19, 2015
• Start date: May 2010
• Est. completion date: June 2013

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Relapsing-remitting multiple sclerosis

• Age 18+

• Patients initiating Betaferon treatment

Exclusion Criteria:

• Patients previously treated with any immunomodulatory drug

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Treatment adherence		12 months	No
Secondary	Clinical course of the disease		12 months	No
Secondary	Overall treatment tolerability as measured by rate of adverse events		12 months	Yes

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