Trial Outcomes & Findings for Genetic and Biochemical Markers of Interferon-Induced Depression. (NCT NCT00252538)
NCT ID: NCT00252538
Last Updated: 2014-12-11
Results Overview
Structured psychiatric interviews and symptom rating scales for depression were used as primary outcome measures to determine the association between phenotype (interferon-induced depression) and genotype (genes that confer risk of interferon-induced depression). Genes of interest related to development of depression and antiviral treatment response that may confer risk for interferon induced depression were examined. this was a multi-site study and included participants from several hospital settings. Three polymorphisms of the interleukin (IL)-28b gene were examined - the c/c, c/t and t/t - and the relationship to MDD was examined. P-values above 0.05 are considered statistically insignificant in this study. In a subsequent analysis of only VA participants proinflammatory cytokines and serotonin levels were examined relative to symptoms of depression.
COMPLETED
133 participants
The proposed enrollment began after funding notification and enrollment will last for a period of 40 months and until end of study.
2014-12-11
Participant Flow
A total of 133 participants from non- VA and VA sites were included for the genetic analysis. Patients from VA sites were recruited through/ referred by the local hepatology clinics. Recruitment occured from 4/6/2006 to 9/1/2009. A second manuscript included VA participants only.
Exclusion Criteria: 1. Diagnosis of active: depression, psychotic symptoms, or bipolar disorder (or history of bipolar disorder) during the previous 3 months 2. On antidepressant medications for any reason 3. Currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months.
Participant milestones
| Measure |
Group 1 MDD
Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD
|
Group 2 Non MDD
Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD
|
|---|---|---|
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Overall Study
STARTED
|
19
|
114
|
|
Overall Study
COMPLETED
|
19
|
114
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetic and Biochemical Markers of Interferon-Induced Depression.
Baseline characteristics by cohort
| Measure |
Group 1
n=133 Participants
Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol.
|
|---|---|
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Age, Continuous
|
49.1 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The proposed enrollment began after funding notification and enrollment will last for a period of 40 months and until end of study.Population: This is an observational study that segregates patients with HCV and on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD. total sample from multiple sites.
Structured psychiatric interviews and symptom rating scales for depression were used as primary outcome measures to determine the association between phenotype (interferon-induced depression) and genotype (genes that confer risk of interferon-induced depression). Genes of interest related to development of depression and antiviral treatment response that may confer risk for interferon induced depression were examined. this was a multi-site study and included participants from several hospital settings. Three polymorphisms of the interleukin (IL)-28b gene were examined - the c/c, c/t and t/t - and the relationship to MDD was examined. P-values above 0.05 are considered statistically insignificant in this study. In a subsequent analysis of only VA participants proinflammatory cytokines and serotonin levels were examined relative to symptoms of depression.
Outcome measures
| Measure |
Group 1- MDD
n=19 Participants
Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD
|
Group 2- no MDD
n=114 Participants
Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD
|
|---|---|---|
|
Phenotype and Genotype Based on Presence of Interferon Induced MDD.
|
19 participants
|
114 participants
|
Adverse Events
Group 1
Serious adverse events
| Measure |
Group 1
n=133 participants at risk
Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol.
|
|---|---|
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Gastrointestinal disorders
Elevation of Alpha Fetoprotein
|
0.75%
1/133 • Number of events 1 • 4/6/2006 - 9/1/2009 ( 3 years and 5 months)
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place