Impact on QoL and Cognitive Functioning of New Antiviral Therapies in Subjects With Chronic Hepatitis HCV-related

NCT03313154 | Completed

• 1 other identifier: PG/2015/16964
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic hepatitis HCV-related is the most common cause of chronic liver disease in Italy. Patients with chronic hepatitis C present a prevalence of depressive disorders higher than that of the general population; moreover, it has been repeatedly demonstrated the presence of cognitive deficits and poor quality of life. Chronic hepatitis C therapy was based on the combined use of pegylated alpha-interferons (PEG-INF), and ribavirin. Recently, new therapeutic protocols have been introduced, and while some antiviral drugs, including the first-generation ones, were used only in combination with PEG-IFN and ribavirin, the second and third generation antiviral drugs protocols are interferon-free. However, because of the high cost, the access to interferon-free protocols is only for patients with advanced fibrous stages, or with concomitant extra-hepatic HCV-related diseases, or for transplanted patients. Many side effects, such as flu-like symptoms, and psychiatric symptoms (depression, anxiety, irritability, insomnia) are common during antiviral therapy with IFN. However, in patients with chronic hepatitis C, a high lifetime prevalence of major depressive disorder, panic disorder, and brief recurrent depression have been observed, irrespective of IFN treatment and the use of alcohol and narcotics; such associations between mood and anxiety disorders and chronic hepatitis C may reflect a high prevalence of bipolar spectrum disorders. The presence of severe psychopathological symptoms requires the reduction of posology and causes high rates of discontinuation of antiviral therapy. This project represents an innovative psychiatric and neuropsychological screening program for patients with chronic hepatitis C, eligible for antiviral therapy.

1. 1.Primary objectives:
2. 2.to verify the medium-term impact of new antiviral therapies on quality of life, psychological well-being and cognitive function in subjects with chronic hepatitis C;
3. 3.to verify the predictability of specific psychopathological components and specific determinants on compliance with new antiviral therapies.
4. 4.Main secondary objectives:
5. 5.to verify the evidence of association between various psychiatric disorders and cognitive deficits and chronic hepatitis C;
6. 6.to evaluate the relative weight of psychopathological and/or cognitive disorders on the efficacy of antiviral therapy and on quality of life.

Conditions

Psychiatric Disorders; Cognitive Impairment; Chronic Hepatitis c

Keywords

Quality of Life; Psychiatric comorbidity; Cognitive impairment; Chronic Hepatitis HCV-related

Outcome Measures

Primary Outcomes (1)

• Short Form Health Survey-12 item (SF-12)

  Self-report questionnaire that examines the following dimensions of well-being: vitality, physical function, physical pain, perception of general health, mental, physical, and emotional health, social role.

  Baseline (T0), and change from baseline at three (T4) and six (T7) months

Secondary Outcomes (8)

• Advanced Neuropsychiatric Tools and Assessment Schedule (ANTAS)

  Baseline (T0)

• Hamilton Scale for Depression (HAM-D)

  Baseline (T0), and change from baseline at three (T4) and six (T7) months

• Patient's Health Questionnaire-9 items (PHQ-9)

  Baseline (T0), and change from baseline: at two (T1) and four (T2) weeks, two (T3), three (T4), four (T5), five (T6), and six (T7) months.

• Mood Disorders Questionnaire (MDQ)

  Baseline (T0)

• Young Mania Rating Scale (YMRS)

  Baseline (T0), and change from baseline at three (T4) and six (T7) months

Study Arms (2)

Neuropsychiatric screening (treatment+)

Subjects affected by chronic hepatitis HCV-related, undergoing new antiviral drugs treatment, will be screened by psychiatric and neuropsychological questionnaires/tests

Other: Neuropsychiatric screening

Neuropsychiatric screening (treatment-)

Subjects affected by chronic hepatitis HCV-related, in wait list for new antiviral drugs treatment, will be screened by psychiatric and neuropsychological questionnaires/tests

Other: Neuropsychiatric screening

Interventions

Neuropsychiatric screening OTHER

Psychiatric diagnosis through: 1. clinical interview 2. the Advanced Neuropsychiatric Tools and Assessment Schedule (ANTAS), based on the SCID-I-NP (Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-Non Patient Version); 3. HAM-D (Hamilton Scale for Depression); 4. PHQ-9 (Patient's Health Questionnaire-9 items); 5. MDQ (Mood Disorders Questionnaire); 6. YMRS (Young Mania Rating Scale); 7. ASRM (Altman Self Rating Mania scale); 8. BRIAN (Biological Rhythms Interview of Assessment in Neuropsychiatry). Assessment of Quality of Life: 9. SF-12 (Short Form Health Survey-12 items). Neuropsychological screening: l) Addenbrooke's Cognitive Examination (ACE-R).

Neuropsychiatric screening (treatment+); Neuropsychiatric screening (treatment-)

Eligibility Criteria

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

Study Population

Group 1: 50 subjects with chronic hepatitis HCV-related, which are eligible to be immediately treated with new antiviral drugs. Group 2: 50 subjects with chronic hepatitis HCV-related, which are eligible to be treated with new antiviral drugs but are in wait list.

You may qualify if:

• diagnosis of chronic hepatitis HCV-related, eligible to new antiviral drugs treatments
• understanding Italian language
• signed informed consent

You may not qualify if:

• severe cognitive deficits

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria di Cagliari: lead

Study Sites (1)

Policlinico Universitario di Monserrato

Monserrato, Cagliari, 09042, Italy

Location

Related Publications (8)

• Alter MJ. Epidemiology of hepatitis C virus infection. World J Gastroenterol. 2007 May 7;13(17):2436-41. doi: 10.3748/wjg.v13.i17.2436.

  PMID: 17552026 RESULT

• Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol. 2006 Oct;45(4):529-38. doi: 10.1016/j.jhep.2006.05.013. Epub 2006 Jun 23.

  PMID: 16879891 RESULT

• Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Psychiatric symptoms in patients with chronic hepatitis C receiving interferon alfa-2b therapy. J Clin Psychiatry. 2003 Jun;64(6):708-14. doi: 10.4088/jcp.v64n0614.

  PMID: 12823087 RESULT

• Foster GR, Goldin RD, Thomas HC. Chronic hepatitis C virus infection causes a significant reduction in quality of life in the absence of cirrhosis. Hepatology. 1998 Jan;27(1):209-12. doi: 10.1002/hep.510270132.

  PMID: 9425939 RESULT

• Carta MG, Hardoy MC, Garofalo A, Pisano E, Nonnoi V, Intilla G, Serra G, Balestrieri C, Chessa L, Cauli C, Lai ME, Farci P. Association of chronic hepatitis C with major depressive disorders: irrespective of interferon-alpha therapy. Clin Pract Epidemiol Ment Health. 2007 Oct 23;3:22. doi: 10.1186/1745-0179-3-22.

  PMID: 17956625 RESULT

• Carta MG, Angst J, Moro MF, Mura G, Hardoy MC, Balestrieri C, Chessa L, Serra G, Lai ME, Farci P. Association of chronic hepatitis C with recurrent brief depression. J Affect Disord. 2012 Dec 10;141(2-3):361-6. doi: 10.1016/j.jad.2012.03.020. Epub 2012 May 18.

  PMID: 22609196 RESULT

• Kraus MR, Schafer A, Teuber G, Porst H, Sprinzl K, Wollschlager S, Keicher C, Scheurlen M. Improvement of neurocognitive function in responders to an antiviral therapy for chronic hepatitis C. Hepatology. 2013 Aug;58(2):497-504. doi: 10.1002/hep.26229. Epub 2013 Jun 24.

  PMID: 23300053 RESULT

• Mura G, Chessa L, Manca A, Preti A, Balestrieri C, Onali S, Carta MG. Impact of direct-acting antiviral drugs for chronic hepatitis C on mood: Preliminary results from a longitudinal study. Gen Hosp Psychiatry. 2019 Jan-Feb;56:50-51. doi: 10.1016/j.genhosppsych.2018.10.008. Epub 2018 Nov 14. No abstract available.

  PMID: 30470569 DERIVED

MeSH Terms

Conditions

Mental Disorders; Cognitive Dysfunction; Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gioia Mura, Dr

  Azienda Ospedaliero Universitaria di Cagliari

  PRINCIPAL INVESTIGATOR

• Mauro G Carta, Prof

  Azienda Ospedaliero Universitaria di Cagliari

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 18, 2017
• Study Start: November 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

IT (1)