CompletedPhase 2

Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients

Spain133 participantsStarted 2005-03

Plain-language summary

The purpose of this study is to determine whether the use of an antidepressant (escitalopram) can prevent depressive episodes that appear during the treatment with peg-interferon and ribavirin in patients with chronic hepatitis C.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with chronic hepatitis C who are going to initiate treatment with peginterferon alfa2a + ribavirin. * Age 18-65 years. * Signed informed consent. * If female, they are not in fertile period or they use barrier contraceptives. * Patients able to understand and fill written questionnaires. Exclusion Criteria: * Hepatic cirrhosis or carcinoma. * Less than 4000/mm3 leucocytes, or less than 70000/mm3 platelets. * Hemoglobin less than 11 g/dL (females) or 12 (males). * Any risk factor for hemolysis. * Comorbid severe medical conditions (kidney, immune system, lung, heart, thyroid, etc). * Baseline mental disorders that require antidepressants (depressive disorders and anxiety disorders). * Other baseline mental disorders (delirium, substance use disorders). * Mental disorders at any time (dementia, psychotic disorders, bipolar disorders. * Contraindications of escitalopram (hypersensibility, diabetes, patients using serotoninergic agents, drugs that enhance the risk of bleeding, or monoamineoxidase inhibitors -MAOIs-).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.

Timeframe: First three months of interferon treatment.

Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).

Timeframe: Six months after the end of interferon treatment

Trial details

NCT IDNCT00166296

SponsorGermans Trias i Pujol Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-10

Results submitted2011-02-08

View on ClinicalTrials.gov More Major Depressive Disorder trials