N/A
N=133
Genetic and Biochemical Markers of Interferon-Induced Depression.
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00252538 ↗Enrolled (actual)
133
Serious AEs
0.8%
Results posted
Dec 2014
Primary outcome: Primary: Phenotype and Genotype Based on Presence of Interferon Induced MDD. — 19; 114 participants — p=>0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phenotype and Genotype Based on Presence of Interferon Induced MDD. |
19; 114 | >0.05 |
Summary
The purpose of this study is to identify predictors and associated biochemical markers of interferon-induced depression. It is hypothesized that genetic variation in genes related to the serotonergic system may predict vulnerability to interferon-induced depression.
Eligibility Criteria
Inclusion Criteria
- Serum positive for hepatitis C
- Age 18 or older
- Not pregnant and using adequate contraception
- Hepatologist-determined patient is a candidate for interferon therapy
- Written/signed informed consent specific for this protocol has been obtained prior to entry
Exclusion Criteria
- Diagnosis of active: depression, psychotic symptoms, or bipolar disorder (or history of bipolar disorder) during the previous 3 months
- On antidepressant medications for any reason
- Currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months.
Data sourced from ClinicalTrials.gov (NCT00252538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.