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Depression, Genes, Cytokines, Chronic Fatigue, Physical Illnesses and Quality of Life

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ClinicalTrials.gov Identifier: NCT02943330
Recruitment Status : Completed
First Posted : October 24, 2016
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chih-Ken Chen, Chang Gung Memorial Hospital

Brief Summary:
Depression is one of the most common psychiatric diseases, with prevalence estimates ranging from 5% to 20%. Depression is now recognized as a brain disease; it can be managed and treated effectively with a wide range of options, but its biological basis is still far from clear. Studies of monozygotic and dizygotic twin pairs suggest polygenic inheritance, with an overall heritability estimate between 40% and 70 %. Gene-environment interaction has been recognized for a long time in the pathophysiology of depression, and its best biological substratum at present is represented by the serotonin transporter (5-HTT) gene. It would be interesting to study association between the novel allelic variants or at least the triallelic 5-HTTLPR polymorphism and depression. Depression is common in patients with end-stage renal disease and to occur in about 20% to 30% of hemodialysis patients. Interferon-induced depression is estimated up to 50% among patients with hepatitis C. Several sets of observations support the supposition that cytokines, and proinflammatory cytokines in particular, are involved in depressive disorders. Depression sufferers have been reported to have elevated blood levels of interleukin 1 (IL-1), IL-6 and tumor necrosis factor α (TNF-α).

Condition or disease Intervention/treatment
Hemodialysis Hepatitis C Other: Questionnaire

Detailed Description:
The aim of this study is to examine the relations between depression and psychiatric family history, candidate genes, cytokines and health-related quality of life among hemodialysis patients and patients receiving interferon treatment for hepatitis C. The investigators aim to recruit 200 hemodialysis patients and 100 patients receiving interferon treatment for hepatitis C at Chang Gung Memorial Hospital, Keelung. Our pilot study found that among hemodialysis patients, the prevalence rates of probable anxiety disorder and probably depression disorder was 25.9% and 40.0%. Among the patients receiving interferon treatment for hepatitis C, the prevalence rates of probable anxiety disorder and probably depression disorder was 30.2% and 20.7% at baseline, and 44.0% and 36.2% at 3 months after interferon treatment. The study procedure consists of 2 parts. For the first one, all the recruited hemodialysis patients will receive assessments for fatigue symptoms using Fatigue Scale, depressive symptoms using Hospital Anxiety and Depression Scale (HADS) and Montgomery Asberg Depression Rating Scale (MADRS), Short-form Health-related Quality of Life (SF-36), blood levels of IL-1β, IL-6 and TNF-αas well as psychiatric diagnostic interview with the Mini-International Neuropsychiatric Interview (MINI) and the Family Interview for Genetic Study (FIGS). The second one is a prospective follow up of patients receiving interferon treatment. Before initiating interferon treatment, the subjects will receive baseline assessments using the same scales mentioned above. The investigators will genotype the 5-HTTLPR triallelic polymorphism on all subjects. The follow-up visits are at month 1, month 3, termination, and one month after termination of interferon program. This proposed project will provide a broad view and better understanding of the gene-environment interaction in the etiology of depression.

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Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relation Between Depression, Genes, Cytokines, Chronic Fatigue, Physical Illnesses and Quality of Life
Study Start Date : August 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hemodialysis
Hemodialysis patients
Other: Questionnaire
Questionnaires such as Hospital Anxiety and Depression Scale (HADS) and Montgomery Asberg Depression Rating Scale (MADRS), Short-form Health-related Quality of Life (SF-36), as well as psychiatric diagnostic interview with the Mini-International Neuropsychiatric Interview (MINI) and the Family Interview for Genetic Study (FIGS).

Hepatitis C
Patients receiving interferon treatment for hepatitis C
Other: Questionnaire
Questionnaires such as Hospital Anxiety and Depression Scale (HADS) and Montgomery Asberg Depression Rating Scale (MADRS), Short-form Health-related Quality of Life (SF-36), as well as psychiatric diagnostic interview with the Mini-International Neuropsychiatric Interview (MINI) and the Family Interview for Genetic Study (FIGS).




Primary Outcome Measures :
  1. Psychiatric diagnosis [ Time Frame: 3 years ]
    Psychiatric diagnosis will be made according to DSM IV criteria after a structured psychiatric diagnosis interview with the Mini-International Neuropsychiatric Interview (MINI).


Secondary Outcome Measures :
  1. Psychiatric family history [ Time Frame: 3 years ]
    Psychiatric family history will be obtained by interviewing with the Chinese version of the Diagnostic Interview for Genetic Study. Based on the informant's responses to the general screening questions, five symptom checklists (depression, mania, alcohol and other drug abuse, psychosis, paranoid/schizoid/ schizotypal personality disorder) were completed for each first-degree relative.

  2. Hospital Anxiety and Depression Scale [ Time Frame: 3 years ]
    Depressive symptoms will be evaluated using Hospital Anxiety and Depression Scale (HADS) and Montgomery Asberg Depression Rating Scale (MADRS). The HADS is a self-reported scale, and consists of 14 items (7 for anxiety and 7 for depression), which has been frequently applied to assess anxiety and depression symptoms of medically ill patients.

  3. Montgomery Asberg Depression Rating Scale [ Time Frame: 3 years ]
    The MADRS is a rating scale for severity of depressive mood symptoms. The scale consists of 10 items. Each item is rated from 0 to 6. The MADRS total score is the sum of the 10 items, and the score ranges from 0 to 60.

  4. Quality of life [ Time Frame: 3 years ]

    Quality of life will be assessed using the Short-form Health-related Quality of Life (SF-36) . This questionnaire assesses eight dimensions of physical and mental health, and the range is from 100 (optimal) to zero (poorest): physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health.

    The SF-36 has demonstrated sensitivity to change, and score changes can be interpreted as changes in the health-related quality of life of the patient.


  5. Fatigue symptoms [ Time Frame: 3 years ]
    Fatigue symptoms will be evaluated using the self-reported Fatigue Scale.

  6. Cytokines [ Time Frame: 3 years ]
    The levels of interleukin 1, interleukin 6, tumor necrosis factor α, DHEA, and DHEA-S will be tested via standard ELISA protocol.

  7. Genotyping [ Time Frame: 3 years ]
    The Genomic DNA will be extracted from peripheral blood by standard methods.


Biospecimen Retention:   Samples With DNA
IL-1β, IL-6 and TNF-α, as well as genotype the 5-HTTLPR triallelic polymorphism on all subjects.


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:   Probability Sample
Study Population
We aim to recruit 200 demodialysis patients and 100 patients receiving interferon treatment for hepatitis C at Chang Gung Memorial Hospital, Keelung.
Criteria

Inclusion Criteria:

  • Aged 18 years old or more, both males and females
  • Agree to participate and able to write Informed consent.

Exclusion Criteria:

  • No specific exclusion criteria.

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): NCT02943330


Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
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Principal Investigator: Chih-Ken Chen, MD, PhD Chang Gung Memorial Hospital

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chih-Ken Chen, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02943330     History of Changes
Other Study ID Numbers: 98-2314-B-182-023-MY3
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chih-Ken Chen, Chang Gung Memorial Hospital:
Depression
Cytokines
Hemodialysis
Interferon treatment
Hepatitis C

Additional relevant MeSH terms:
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Depression
Hepatitis
Hepatitis C
Fatigue
Behavioral Symptoms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Signs and Symptoms