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Completed

NCT Number: NCT01957319

Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability

Background: Hepatitis C virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life.

Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.

Patients and Methods: In this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (Group A) with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).

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Key information

Conditions

Work Ability Behavior Behavioral Symptoms Depression

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Catania, Cannizzaro Hospital

Catania, 95125, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HCV infection

Exclusion criteria

  • cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy hemoglobinopathies hemocromatosis

Treatment and study plan

Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg

Drug

Sugar pill

Drug

Primary outcomes

  1. Work ability index

    Time frame: 12 months

    Administration of questionnaire(Work ability Index - WAI)The work ability index is a tool to record the work ability of employees. It aims at identifying, at an early stage, health risks of early retirement an counteracting them. The questionnaire is aimed at: 1) the estimated current and future work ability; 2) diagnosed illness and the number of absenteeism days in the previous year; 3) the estimated sickness-related deterioration in the work performance; 4) mental ability reserves. The WAI evaluates current work ability compared with lifetime and in relation to the demands of the job, number of current diseases diagnosed by a physician, estimated work impairment due to diseases.

Secondary outcomes

  1. depression

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Oct 8, 2013

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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