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Completed

NCT Number: NCT01354665

Depression and Fatigue in MS Patients Treated With Betaferon.

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients previously treated with any immunomodulatory drug

Treatment and study plan

Interferon beta-1b (Betaferon, BAY86-5046)

Biological

Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Treatment adherence

    Time frame: 12 months

  3. Clinical course of the disease

    Time frame: 12 months

  4. Overall treatment tolerability as measured by rate of adverse events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Acronym: FADO

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 17, 2011
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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