- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136318
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
Status
Completed
Conditions
Intervention / Treatment
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
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Leipzig, Germany, 04103
- Department of Gastroenterolgy and Rheumatology, Sektion Hepatology
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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.
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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:
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.
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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.
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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:
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.
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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
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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)
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50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3
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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
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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
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Patients free of depression during 24 or 48 weeks of antiviral therapy
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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
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major depression during 24 or 48 weeks of antiviral therapy
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Severe Depression Defined as a MADRS Score of 25 or Higher
Time Frame: severe depression during 24 or 48 weeks of antiviral therapy
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severe depression during 24 or 48 weeks of antiviral therapy
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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
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assessed 2,4,12,24 and 48 weeks of antiviral treatment
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Sustained Virologic Response
Time Frame: assessed 24 weeks after end of antiviral treatment
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(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)
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assessed 24 weeks after end of antiviral treatment
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Tolerability
Time Frame: assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
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assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
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Safety
Time Frame: assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
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assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment
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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.
General Publications
- Sarkar S, Sarkar R, Berg T, Schaefer M. Sadness and mild cognitive impairment as predictors for interferon-alpha-induced depression in patients with hepatitis C. Br J Psychiatry. 2015 Jan;206(1):45-51. doi: 10.1192/bjp.bp.113.141770. Epub 2014 Oct 30.
- Schaefer M, Sarkar R, Knop V, Effenberger S, Friebe A, Heinze L, Spengler U, Schlaepfer T, Reimer J, Buggisch P, Ockenga J, Link R, Rentrop M, Weidenbach H, Fromm G, Lieb K, Baumert TF, Heinz A, Discher T, Neumann K, Zeuzem S, Berg T. Escitalopram for the prevention of peginterferon-alpha2a-associated depression in hepatitis C virus-infected patients without previous psychiatric disease: a randomized trial. Ann Intern Med. 2012 Jul 17;157(2):94-103. doi: 10.7326/0003-4819-157-2-201207170-00006.
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Mood Disorders
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Depression
- Depressive Disorder
- Hepatitis C
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
- Ribavirin
- Peginterferon alfa-2a
Other Study ID Numbers
- ML18075
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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