Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133276
Status:
COMPLETED
Last Update Posted:
2010-02-19
First Post:
2005-08-22
Brief Title:
Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
Prophylactic Treatment of Peginterferon-associated Psychopathology A Double-blind Placebo-controlled Trial on the Effects of Escitalopram Lexapro in Patients Treated With Peginterferon and Ribavirin POPS Study
Status:
COMPLETED
Status Verified Date:
2010-02
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:
None
Brief Summary:
The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but is hampered by peginterferon-induced psychopathology
Prevention of peginterferon-induced psychopathology with selective serotonin reuptake inhibitors SSRIs paroxetine has been shown to be effective in patients treated with interferon for malignant disease The aim is to study the effects of prophylactic treatment with escitalopram another SSRI on peginterferon-associated psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis C
Prevention of peginterferon-induced psychopathology with selective serotonin reuptake inhibitors SSRIs paroxetine has been shown to be effective in patients treated with interferon for malignant disease The aim is to study the effects of prophylactic treatment with escitalopram another SSRI on peginterferon-associated psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis C
Detailed Description:
The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but is hampered by peginterferon-induced psychopathology
Prevention of peginterferon-induced psychopathology with SSRIs paroxetine has been shown to be effective in patients treated with interferon for malignant disease The aim is to study the effects of prophylactic treatment with escitalopram on peginterferon-associated psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis C
Design double blind randomized controlled trial with two arms maximum 40 patients per arm Patients starting with peginterferon and ribavirin will be randomized to receive escitalopram therapy 10 mg per day however 5 mg in the first two weeks or placebo
Study population and selection eighty patients receiving peginterferon alfa-2a Pegasys 180 microgram and ribavirin Copegus 400 mg twice daily will be included in the study
Aims of the study
1 to asses whether prophylactic treatment with escitalopram avoids significantly the occurrence of peginterferon-induced psychiatric disturbance defined as an increase of two points on observer-based rating scales reflecting anxiety BASBriefAnxietyScale loss of concentration depression and loss of impulse control Montgomery and Asberg Depression Rating Scale MADRS and
2 to assess the frequency of major depression according to DSM IV criteria in the escitalopram and placebo-treated patients
Prevention of peginterferon-induced psychopathology with SSRIs paroxetine has been shown to be effective in patients treated with interferon for malignant disease The aim is to study the effects of prophylactic treatment with escitalopram on peginterferon-associated psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis C
Design double blind randomized controlled trial with two arms maximum 40 patients per arm Patients starting with peginterferon and ribavirin will be randomized to receive escitalopram therapy 10 mg per day however 5 mg in the first two weeks or placebo
Study population and selection eighty patients receiving peginterferon alfa-2a Pegasys 180 microgram and ribavirin Copegus 400 mg twice daily will be included in the study
Aims of the study
1 to asses whether prophylactic treatment with escitalopram avoids significantly the occurrence of peginterferon-induced psychiatric disturbance defined as an increase of two points on observer-based rating scales reflecting anxiety BASBriefAnxietyScale loss of concentration depression and loss of impulse control Montgomery and Asberg Depression Rating Scale MADRS and
2 to assess the frequency of major depression according to DSM IV criteria in the escitalopram and placebo-treated patients
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