Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317746
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2006-04-21
Brief Title:
Trial of Citalopram for the Prevention of Depression
Sponsor:
Marina Klein
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
A Randomized Placebo Controlled Trial of Citalopram for the Prevention of Depression and Its Consequences in HIV-Hepatitis C Co-infected Individuals Initiating Pegylated InterferonRibavirin Therapy
Status:
COMPLETED
Status Verified Date:
2017-05
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:
PICCO
Brief Summary:
With the improved prognosis of human immunodeficiency virus HIV infection end stage liver disease due to hepatitis C HCV now represents a major cause of morbidity and mortality in people with HIV Treatment for HCV has become increasingly important as a means of preventing the consequences of chronic HCV infection Paradoxically co-infected patients have low rates of treatment initiation and completion in large part because they have a high risk of developing neuropsychiatric symptoms while receiving PEG-interferon PEG-IFN There are a large number of co-infected individuals in Canada who could benefit from HCV therapy if tolerability could be improved This trial will address whether prophylactic use of antidepressants in HIV-HCV infected patients initiating HCV therapy can prevent the development of neuropsychiatric side effects and thus permit more patients to receive full treatment for HCV
Detailed Description:
Trial design
This study is a Canadian multicentre randomized double-blind placebo controlled trial We will evaluate whether prophylactic citalopram compared to symptomatic treatment of depression can significantly increase the amount of HCV therapy received in co-infected patients during the first 24 weeks Post study follow-up will extend until 6 months after cessation of HCV therapy up to 72 weeks to capture information on SVR sustained virologic response for HCV 76 patients will be randomized in a 11 ratio to citalopram or placebo Patients will be stratified by study centre and HCV genotype Citalopram or placebo will begin 3 weeks before HCV treatment at an initial dose of 10 mg per day then be increased to 20 mg per day after one week and continued throughout treatment with PEG-IFNribavirin up to 48 weeks and then tapered to discontinuation at completion of HCV therapy The management of depression emerging in study participants is mandated in the protocol to ensure that the original treatment assignments remain blinded while allowing for all subjects to remain in the study and mimics what would take place in clinical practice
Analysis
The analyses will follow the intention-to-treat approach Random regression modelling will be employed to analyse longitudinal data on adherence to prescribed PEG-IFN and ribavirin dosage at weeks 12 and 24 Survival analyses will be used to compare the two treatment groups with respect to the time to the development of depressions
Implications
Prophylactic antidepressants may not only prevent overt depression but may also diminish the development of sub-clinical depressed mood Effective prevention of a broad range of neuropsychiatric symptoms by use of citalopram has the potential to diminish morbidity associated with PEG-IFN treatment and consequently allow a greater number of patients to complete full therapy In addition such an approach may help patients remain adherent to their HIV therapy during the course of HCV treatment which could have long-term personal and public health implications by preventing the emergence of HIV resistance Furthermore if shown to be an effective strategy for preventing neuropsychiatric symptoms treatment for HCV may become more accessible to the large number of patients who may not have ready access to the frequent and intensive psychiatric monitoring necessary for the early detection and treatment of depression that manifests on PEG-IFN
This study is a Canadian multicentre randomized double-blind placebo controlled trial We will evaluate whether prophylactic citalopram compared to symptomatic treatment of depression can significantly increase the amount of HCV therapy received in co-infected patients during the first 24 weeks Post study follow-up will extend until 6 months after cessation of HCV therapy up to 72 weeks to capture information on SVR sustained virologic response for HCV 76 patients will be randomized in a 11 ratio to citalopram or placebo Patients will be stratified by study centre and HCV genotype Citalopram or placebo will begin 3 weeks before HCV treatment at an initial dose of 10 mg per day then be increased to 20 mg per day after one week and continued throughout treatment with PEG-IFNribavirin up to 48 weeks and then tapered to discontinuation at completion of HCV therapy The management of depression emerging in study participants is mandated in the protocol to ensure that the original treatment assignments remain blinded while allowing for all subjects to remain in the study and mimics what would take place in clinical practice
Analysis
The analyses will follow the intention-to-treat approach Random regression modelling will be employed to analyse longitudinal data on adherence to prescribed PEG-IFN and ribavirin dosage at weeks 12 and 24 Survival analyses will be used to compare the two treatment groups with respect to the time to the development of depressions
Implications
Prophylactic antidepressants may not only prevent overt depression but may also diminish the development of sub-clinical depressed mood Effective prevention of a broad range of neuropsychiatric symptoms by use of citalopram has the potential to diminish morbidity associated with PEG-IFN treatment and consequently allow a greater number of patients to complete full therapy In addition such an approach may help patients remain adherent to their HIV therapy during the course of HCV treatment which could have long-term personal and public health implications by preventing the emergence of HIV resistance Furthermore if shown to be an effective strategy for preventing neuropsychiatric symptoms treatment for HCV may become more accessible to the large number of patients who may not have ready access to the frequent and intensive psychiatric monitoring necessary for the early detection and treatment of depression that manifests on PEG-IFN
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Schering 2229 | None | None | None |