Psychobiological Characterization of Depression in Hepatitis C

NCT01492478 | Unknown

• 1 other identifier: 39772
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Depression; Hepatitis c

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are selected in the context of hospital consultancies (Viral Hepatitis Consultancies at the Hospital de Santa Maria; Psychiatric Consultancies at the Hospital de Santa Maria) after informing, requesting voluntary cooperation, confidenciality assurance and with request of informed consent signature, submitted and approved by the hospital's ethics committee

You may qualify if:

• minimum education;
• ages between 18 and 65 years old;
• with diagnosis of Hepatitis C for at least 6 months, newly diagnosed and treatment naive;
• and diagnosis of Major Depression for the control group.

You may not qualify if:

• consumption of opiates, cocaine or other recreational drugs in the 6 months prior to the beginning of the research;
• use of anti-inflammatory drugs and antidepressants;
• history of neurological, infectious or tumoral pathology, at SNC level;
• severe physical deterioration incompatible with the situation being evaluated.

Sponsors & Collaborators

• Centro Hospitalar Lisboa Norte: lead

Study Sites (1)

Faculty of Medicice of Lisbon

Lisbon, Portugal

Location

MeSH Terms

Conditions

Depression; Hepatitis C

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• David Pires Barreira, Dr.

  Centro Hospitalar Lisboa Norte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 15, 2011

Record last verified: 2011-12

Locations

PT (1)