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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: H. Lundbeck A/S; Hoffmann-La Roche
• Treatments: Citalopram; Dexetimide; Interferons; Peginterferon alfa-2a

Criteria

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-).