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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Escitalopram

Escitalopram, 15 mg/day

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

15 mg/day starting 2 weeks before and 12 weeks during interferon therapy

Placebo pill

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.

Interventions

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Escitalopram

15 mg/day starting 2 weeks before and 12 weeks during interferon therapy

Intervention Type DRUG

Placebo

Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.

Intervention Type DRUG

Other Intervention Names

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Cipralex

Eligibility Criteria

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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-).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No