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

NCT01957319 | Completed Phase 3 DMC

• 1 other identifier: 12/1997
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Work Ability; Depression

Outcome Measures

Primary Outcomes (1)

• Work ability index

  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.

  12 months

Secondary Outcomes (1)

• depression

  12 months

Study Arms (2)

Silybin - vitamin E - phospholipids complex

ACTIVE COMPARATOR

Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months.

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

placebo

PLACEBO COMPARATOR

sugar pill

Drug: sugar pill

Interventions

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

Silybin - vitamin E - phospholipids complex

sugar pill DRUG

placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV infection

You may not qualify if:

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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

University of Catania, Cannizzaro Hospital

Catania, 95125, Italy

Location

Related Publications (1)

• Malaguarnera G, Bertino G, Chisari G, Motta M, Vecchio M, Vacante M, Caraci F, Greco C, Drago F, Nunnari G, Malaguarnera M. Silybin supplementation during HCV therapy with pegylated interferon-alpha plus ribavirin reduces depression and anxiety and increases work ability. BMC Psychiatry. 2016 Nov 15;16(1):398. doi: 10.1186/s12888-016-1115-z.

  PMID: 27842532 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Silybin; Vitamin E; Phospholipids; Sugars

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Silymarin; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Membrane Lipids; Lipids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 8, 2013
• Study Start: February 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-09

Locations

IT (1)