Major Depressive Disorder Clinical Trial
Official title:
Study of the Efficacy and Safety of Escitalopram for the Prevention of Depressive Episodes Induced by Peg-Interferon Alpha2a and Ribavirin in Chronic Hepatitis C Patients. Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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.
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 treatment option for this condition. In the last years, interferon molecule has been
modified in order to improve tolerance into pegylated interferon.
Interferon-alfa has been associated with a high prevalence of psychiatric side effects,
especially major depression (up to 25% of the cases), which is one of the main concerns about
using this treatment. In fact, major depression is one of the main reasons of treatment
withdrawal and treatment failure.
Major depression induced by interferon-alfa can be successfully treated with antidepressants,
but we don't know if antidepressants can also prevent the development of major depression,
and if this can be a safe intervention. In the literature, there is only one controlled trial
about this issue, in cancer patients, and some open studies in hepatitis C.
In order to evaluate the efficacy, and safety, of an antidepressant (escitalopram) for
preventing peginterferon's induced depressive episodes in patients with chronic hepatitis C,
we have designed this 14-weeks placebo-controlled, double-blind, randomized clinical trial.
Study interventions will be started two weeks before peginterferon + ribavirin's treatment
onset.
Subjects included in the study will be patients with chronic hepatitis C who are going to be
treated with peginterferon-alfa2a + ribavirin, and without mental disorders requiring active
psychotropic treatment.
The main variables studied will be the appearance of a major depressive episode, following
Diagnostic & Statistical Manual of Mental Disorders (DSM-IV) criteria, and the total score on
the Montgomery-Asberg Depression Rating Scale, along three assessment points at 4, 8 and 12
weeks of treatment with interferon. There will also be a follow-up period of up to 6 months
after treatment with interferon is completed.
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