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Completed

NCT Number: NCT00136318

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

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,...)

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Gastroenterolgy and Rheumatology, Sektion Hepatology

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

Placebo

Drug

Peginterferon alfa-2a

Drug

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

Ribavirin

Drug

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. Severe Depression Defined as a MADRS Score of 25 or Higher

    Time frame: severe depression during 24 or 48 weeks of antiviral therapy

  4. 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

  5. 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)

  6. Tolerability

    Time frame: assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment

  7. Safety

    Time frame: assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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.

Acronym: CIPPAD

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 29, 2005
Registry last updated
Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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