Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients
Condition: Major Depressive Disorder; Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

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.
    

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 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.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg/day starting 2 weeks before and 12 weeks during interferon therapy; Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.
Other intervention name(s): Cipralex
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Major depressive disorder, chemically induced.; Peginterferon alfa-2a.; Escitalopram.; Chronic hepatitis C, psychology.; Prophylactic treatment.