Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00136318
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Sponsor:
Charite University, Berlin, Germany
Organization:
Study Overview
Official 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.
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIPPAD
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,...)
* 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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: