Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136318
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2005-08-26
Brief Title:
Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
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
changesgroup 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 eg 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
changesgroup 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 eg 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:
None
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?:
None