Psychobiological Characterization of Depression in Hepatitis C
Recruitment status was: Not yet recruiting
The aim of this study is to do an evaluation of the clinical profile of depression in HCV patients (newly diagnosed and treatment naïve), and in these same individuals, 24 weeks after the beginning of IFN+Ribavirin therapeutics (n=100). To characterize depression associated to HCV with and without interferon (IFN), the investigators will use clinical, behavioral, biochemical and genetic markers, and to distinguish their different symptomatologic dimensions.
The control group will be composed by 100 individuals with Major Depression diagnosis, and not from the general population, because the investigators are not trying to study the incidence of depression in general population, but to characterize the clinical profile of patients with HCV (IFN+Ribavirin) compared to major depression.
Thus, the investigators will total 300 evaluations in 200 individuals, 100 from each group, and considering that the clinical group will be evaluated before the therapeutics and re-evaluated 24 weeks after its beginning.
- Depression in individuals affected by HCV is associated to genetic vulnerability.
- Genetic vulnerability increases the risk of depression when IFN therapeutics is used.
- Depression associated to infection by HCV presents a symptomatological profile that is different from general depression, which is maintained with IFN therapeutics.
- A higher state of depression in the beginning of a treatment, if not treated, is a risk factor to abandoning therapeutics.
- When comparing genders, women present a more severe symptomatological profile than men.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Psychobiological Characterization of Depression in Hepatitis C|
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492478
|Faculty of Medicice of Lisbon|
|Principal Investigator:||David Pires Barreira, Dr.||Centro Hospitalar Lisboa Norte|