Status:
COMPLETED
Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Hoffmann-La Roche
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 pati...
Detailed Description
Chronic hepatitis C is a prevalent condition, and the main cause of chronic liver diseases, including cirrhosis and cancer. Nowadays, interferon-alfa in combination with ribavirin is the main treatmen...
Eligibility Criteria
Inclusion
- 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
- 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-).
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00166296
Start Date
March 1 2005
End Date
October 1 2007
Last Update
August 17 2020
Active Locations (15)
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1
Fundacion Hospital Alcorcon
Alcorcón, Spain
2
Hospital Nuestra Señora de Sonsoles
Ávila, Spain
3
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
4
Hospital del Mar
Barcelona, Spain