NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 2

Sponsor: Germans Trias i Pujol Hospital

Conditions: Major Depressive Disorder, Hepatitis C, Chronic

Interventions: Escitalopram, Placebo

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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-).

Locations (15)

Alcorcón, Spain
Ávila, Spain
Badalona, Spain
Barcelona, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Sabadell, Spain
Salamanca, Spain
Tarrasa, Spain
Valencia, Spain
Valencia, Spain
Valencia, Spain
Zaragoza, Spain