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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03313154
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Gioia Mura, Azienda Ospedaliero Universitaria di Cagliari

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. Primary objectives:

    1. 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;
    2. to verify the predictability of specific psychopathological components and specific determinants on compliance with new antiviral therapies.
  2. Main secondary objectives:

    1. to verify the evidence of association between various psychiatric disorders and cognitive deficits and chronic hepatitis C;
    2. to evaluate the relative weight of psychopathological and/or cognitive disorders on the efficacy of antiviral therapy and on quality of life.

Condition or disease Intervention/treatment
Psychiatric Disorders Cognitive Impairment Chronic Hepatitis c Other: Neuropsychiatric screening

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact on QoL and Cognitive Functioning of New Antiviral Therapies in Subjects With Chronic Hepatitis HCV-related
Actual Study Start Date : November 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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-)
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

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).





Primary Outcome Measures :
  1. Short Form Health Survey-12 item (SF-12) [ Time Frame: Baseline (T0), and change from baseline at three (T4) and six (T7) months ]
    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.


Secondary Outcome Measures :
  1. Advanced Neuropsychiatric Tools and Assessment Schedule (ANTAS) [ Time Frame: Baseline (T0) ]
    semi- structured interview to diagnose most of the psychiatric disorders, consistent with the diagnostic criteria of the DSM IV (Diagnostic and Statistical Manual of Mental Disorders, 4th ed.)

  2. Hamilton Scale for Depression (HAM-D) [ Time Frame: Baseline (T0), and change from baseline at three (T4) and six (T7) months ]
    clinical evaluation scale of the following depressive features: anxiety and somatization, suicidal thoughts, weight loss, cognitive disorders, activity problems, depressive retardation, sleep disturbances, and insight. It consists of 21 items, with scores from 0 to 3. Scoring 8-17 is indicative of mild depression; 18-24 moderate depression; a score> 25 indicates a severe depression.

  3. Patient's Health Questionnaire-9 items (PHQ-9) [ Time Frame: 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. ]
    Self-report questionnaire based on the DSM IV Major Depressive Disorder Diagnostic Criteria, investigating the presence and severity in the previous 2 weeks of 9 depressive symptoms, such as depressed mood, anhedonia, sleep and food disorders, fatigue, difficulty concentrating, motor behavior disorders, loss of self-esteem, suicidal ideation; the cut-off for minor depressive disorder is represented by scores ≥5, the one for major depressive disorder by scores ≥10. The questionnaire can be administrated by phone.

  4. Mood Disorders Questionnaire (MDQ) [ Time Frame: Baseline (T0) ]
    Self-report 17-item questionnaire for lifetime screening of bipolar spectrum disorders (Type I and II Bipolar Disorder), through DSM IV diagnostic criteria; the cut-off is for scores ≥7

  5. Young Mania Rating Scale (YMRS) [ Time Frame: Baseline (T0), and change from baseline at three (T4) and six (T7) months ]
    11-item questionnaire, evaluating the severity of manic/hypomanic symptoms (excitement, dysphoria, logorrhea, disorders of form and content of thought, sleep disturbances, aggression, appearance and clothing, insight). A score ≥12 suggests the presence of a manic/hypomanic episode

  6. Altman Self Rating Mania Scale (ASRM) [ Time Frame: 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. ]
    self-administered 5-item scale that evaluates the presence and severity in the previous week of manic and hypomanic symptoms, such as manic/irritable mood, increased self-esteem, reduced need for sleep, loquacity, hyperactivity; a score ≥ 6 indicates a high likelihood of a manic or hypomanic episode. It can be administered by phone

  7. Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) [ Time Frame: Baseline (T0), and change from baseline at three (T4) and six (T7) months ]
    21-item questionnaires that investigates the difficulties in sleep, daily activities, social relationships, and nutrition, and how these difficulties relate to biological rhythms

  8. Addenbrooke's Cognitive Examination (ACE-R) [ Time Frame: Baseline (T0), and change from baseline at three (T4) and six (T7) months ]
    short cognitive test, which evaluates five cognitive domains: attention/orientation, memory, verbal fluency, language, visual-spatial abilities. The test, with a maximum score of 100 and a mild cognitive impairment cut-off of 66, includes the Mini Mental State Examination (MMSE).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe cognitive deficits

Information from the National Library of Medicine

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): NCT03313154


Locations
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Italy
Policlinico Universitario di Monserrato
Monserrato, Cagliari, Italy, 09042
Sponsors and Collaborators
Azienda Ospedaliero Universitaria di Cagliari
Investigators
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Principal Investigator: Gioia Mura, Dr Azienda Ospedaliero Universitaria di Cagliari
Study Chair: Mauro G Carta, Prof Azienda Ospedaliero Universitaria di Cagliari

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gioia Mura, Dr, Azienda Ospedaliero Universitaria di Cagliari
ClinicalTrials.gov Identifier: NCT03313154    
Other Study ID Numbers: PG/2015/16964
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gioia Mura, Azienda Ospedaliero Universitaria di Cagliari:
Quality of Life
Psychiatric comorbidity
Cognitive impairment
Chronic Hepatitis HCV-related
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Cognitive Dysfunction
Mental Disorders
Problem Behavior
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Cognition Disorders
Neurocognitive Disorders
Behavioral Symptoms
Antiviral Agents
Anti-Infective Agents