Psychobiological Characterization of Depression in Hepatitis C
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|ClinicalTrials.gov Identifier: NCT01492478|
Recruitment Status : Unknown
Verified December 2011 by David Pires Barreira, Centro Hospitalar Lisboa Norte.
Recruitment status was: Not yet recruiting
First Posted : December 15, 2011
Last Update Posted : December 15, 2011
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.
|Condition or disease|
|Depression Hepatitis c|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Psychobiological Characterization of Depression in Hepatitis C|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2015|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492478
|Faculty of Medicice of Lisbon||Not yet recruiting|
|Contact: David Pires Barreira, Dr. +351 966744438 firstname.lastname@example.org|
|Principal Investigator:||David Pires Barreira, Dr.||Centro Hospitalar Lisboa Norte|