Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients (CIPPAD)

March 20, 2013 updated by: M. Schaefer, MD, Charite University, Berlin, Germany

Efficacy and Tolerability of Escitalopram for the Prevention of Pegylated Interferon Alfa Associated Depression in Patients With Chronic Hepatitis C Infection: a Randomized Controlled Trial.

Primary end points

  • incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype)
  • effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram (S-citalopram) on frequency and severity of depression in patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS) and ribavirin, measured by the Montgomery Asberg Depression Scale

Secondary end points

  • time to depression defined as a MADRS score of 13 or higher
  • incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV) criteria
  • severe depression according to MADRS scale (score 25 or higher)
  • Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36)
  • sustained virologic response
  • tolerability
  • safety
  • changes/group differences in other psychiatric depression scales (Hamilton Depression Rating Scale, Beck Depression Inventory)

Other investigations:

  • cognitive function, anxiety (word fluency test, trail making test part A and B, othe scales)
  • Predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as median ALAT values before treatment divided by the upper standard value, HCV-RNA serum concentration level of fibrosis in liver histology, baseline values of the different psychometric scales)
  • alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH)
  • biomarkers (genetic parameters, cytokines,...)

Study Overview

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leipzig, Germany, 04103
        • Department of Gastroenterolgy and Rheumatology, Sektion Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic hepatitis C infection defined as positive anti-HCV antibodies and serum HCV-RNA >1000 IU/ml, naive to antiviral treatment
  • age >18 years

Exclusion Criteria:

  • Antidepressive treatment within the last 3 years
  • Psychiatric diseases including major depressive disorders in past medical history
  • Active substance abuse during the last 12 months
  • Pregnancy, lactation, wish to become pregnant
  • Hepatitis B (HBV)/HIV-coinfection
  • Decompensated liver disease, hepatocellular carcinoma, history of bleeding esophageal varices
  • Neutropenia (<1500/ul), thrombocytopenia (<70/nl), anemia (<12g/dl in females, <13g/dl in males)
  • History of autoimmune disease
  • History of organ transplantation, concomitant liver disease, severe cardiopulmonary disease, hemolytic anemia, malignant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Escitalopram
After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly.
Other Names:
  • Pegasys
  • PEG-IFN alfa-2a
Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks.
PLACEBO_COMPARATOR: Placebo
After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly.
Other Names:
  • Pegasys
  • PEG-IFN alfa-2a
Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher
Time Frame: 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3
Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as "percentage of participants" with "MADRS scores > 13" (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)
50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)
Time Frame: Patients free of depression during 24 or 48 weeks of antiviral therapy
Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression
Patients free of depression during 24 or 48 weeks of antiviral therapy
Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria
Time Frame: major depression during 24 or 48 weeks of antiviral therapy
major depression during 24 or 48 weeks of antiviral therapy
Severe Depression Defined as a MADRS Score of 25 or Higher
Time Frame: severe depression during 24 or 48 weeks of antiviral therapy
severe depression during 24 or 48 weeks of antiviral therapy
Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)
Time Frame: assessed 2,4,12,24 and 48 weeks of antiviral treatment
assessed 2,4,12,24 and 48 weeks of antiviral treatment
Sustained Virologic Response
Time Frame: assessed 24 weeks after end of antiviral treatment
(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)
assessed 24 weeks after end of antiviral treatment
Tolerability
Time Frame: assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
Safety
Time Frame: assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Thomas Berg, Prof. Dr., Charité
  • Study Chair: Martin Schaefer, Prof. Dr., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (ESTIMATE)

August 29, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 20, 2013

Last Verified

March 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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