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

NCT02943330 | Completed

• 1 other identifier: 98-2314-B-182-023-MY3
• Study Type: observational
• Target: 170
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hemodialysis; Hepatitis C

Keywords

Depression; Cytokines; Hemodialysis; Interferon treatment; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Psychiatric family history

  3 years

• Hospital Anxiety and Depression Scale

  3 years

• Montgomery Asberg Depression Rating Scale

  3 years

• Quality of life

  3 years

• Fatigue symptoms

  3 years

Study Arms (2)

Hemodialysis

Hemodialysis patients

Other: Questionnaire

Hepatitis C

Patients receiving interferon treatment for hepatitis C

Other: Questionnaire

Interventions

Questionnaire OTHER

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).

Hemodialysis; Hepatitis C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

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Biospecimen

Retention: SAMPLES WITH DNA

IL-1β, IL-6 and TNF-α, as well as genotype the 5-HTTLPR triallelic polymorphism on all subjects.

MeSH Terms

Conditions

Hepatitis C; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Chih-Ken Chen, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: August 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share