MedTrace Logo

Psychobiological Characterization of Depression in Hepatitis C

NCT01492478 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2011-12-15

No results posted yet for this study

Summary

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.

Hypotheses

1. Depression in individuals affected by HCV is associated to genetic vulnerability.
2. Genetic vulnerability increases the risk of depression when IFN therapeutics is used.
3. Depression associated to infection by HCV presents a symptomatological profile that is different from general depression, which is maintained with IFN therapeutics.
4. A higher state of depression in the beginning of a treatment, if not treated, is a risk factor to abandoning therapeutics.
5. When comparing genders, women present a more severe symptomatological profile than men.

Conditions

Sponsors & Collaborators

  • Centro Hospitalar Lisboa Norte

    lead OTHER

Principal Investigators

  • David Pires Barreira, Dr. · Centro Hospitalar Lisboa Norte

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-07-31
Completion
2015-12-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01492478 on ClinicalTrials.gov