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Psychobiological Characterization of Depression in Hepatitis C

This study is not yet open for participant recruitment.
Verified December 2011 by Centro Hospitalar Lisboa Norte
Sponsor:
Information provided by (Responsible Party):
David Pires Barreira, Centro Hospitalar Lisboa Norte
ClinicalTrials.gov Identifier:
NCT01492478
First received: December 13, 2011
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

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.

Condition
Depression
Hepatitis c

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychobiological Characterization of Depression in Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centro Hospitalar Lisboa Norte:

Estimated Enrollment: 200
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)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492478

Locations
Portugal
Faculty of Medicice of Lisbon Not yet recruiting
Lisbon, Portugal
Contact: David Pires Barreira, Dr.     +351 966744438     davidbarreira@gmail.com    
Sponsors and Collaborators
Centro Hospitalar Lisboa Norte
Investigators
Principal Investigator: David Pires Barreira, Dr. Centro Hospitalar Lisboa Norte
  More Information

No publications provided

Responsible Party: David Pires Barreira, Dr., Centro Hospitalar Lisboa Norte
ClinicalTrials.gov Identifier: NCT01492478     History of Changes
Other Study ID Numbers: 39772
Study First Received: December 13, 2011
Last Updated: December 14, 2011
Health Authority: Portugal: Health Ethic Committee

Additional relevant MeSH terms:
Depression
Depressive Disorder
Hepatitis
Hepatitis A
Hepatitis C
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013