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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943330
• Other study ID #: 98-2314-B-182-023-MY3
• Status: Completed
• Phase: N/A
• First received: October 21, 2016
• Last updated: October 23, 2016
• Start date: August 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Fatigue
• Hemodialysis
• Hepatitis
• Hepatitis C

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychiatric diagnosis	Psychiatric diagnosis will be made according to DSM IV criteria after a structured psychiatric diagnosis interview with the Mini-International Neuropsychiatric Interview (MINI).	3 years	No
Secondary	Psychiatric family history	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.	3 years	No
Secondary	Hospital Anxiety and Depression Scale	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 years	No
Secondary	Montgomery Asberg Depression Rating Scale	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.	3 years	No
Secondary	Quality of life	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.	3 years	No
Secondary	Fatigue symptoms	Fatigue symptoms will be evaluated using the self-reported Fatigue Scale.	3 years	No
Secondary	Cytokines	The levels of interleukin 1, interleukin 6, tumor necrosis factor a, DHEA, and DHEA-S will be tested via standard ELISA protocol.	3 years	No
Secondary	Genotyping	The Genomic DNA will be extracted from peripheral blood by standard methods.	3 years	No