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

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ClinicalTrials.gov Identifier: NCT00136318
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : March 21, 2013
Last Update Posted : March 21, 2013
Sponsor:
Information provided by (Responsible Party):
M. Schaefer, MD, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE August 26, 2005
First Posted Date  ICMJE August 29, 2005
Results First Submitted Date  ICMJE October 25, 2012
Results First Posted Date  ICMJE March 21, 2013
Last Update Posted Date March 21, 2013
Study Start Date  ICMJE January 2004
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
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)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00136318 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
  • 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
  • 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 ]
  • Severe Depression Defined as a MADRS Score of 25 or Higher [ Time Frame: 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 ]
  • 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)
  • Tolerability [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Official Title  ICMJE 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.
Brief Summary

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,...)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Escitalopram
  • Drug: Placebo
  • Drug: Peginterferon alfa-2a
    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:
    • PEG-IFN alfa-2a
    • Pegasys
  • Drug: Ribavirin
    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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Escitalopram
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2013)
208
Original Enrollment  ICMJE
 (submitted: August 26, 2005)
200
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136318
Other Study ID Numbers  ICMJE ML18075
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M. Schaefer, MD, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Thomas Berg, Prof. Dr. Charité
Study Chair: Martin Schaefer, Prof. Dr. Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP