Depression Clinical Trial
Official title:
Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability
Verified date | September 2013 |
Source | University of Catania |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 72 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University of Catania, Cannizzaro Hospital | Catania |
Lead Sponsor | Collaborator |
---|---|
University of Catania |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | depression | 12 months | Yes |
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