- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02943330
Depression, Genes, Cytokines, Chronic Fatigue, Physical Illnesses and Quality of Life
Relation Between Depression, Genes, Cytokines, Chronic Fatigue, Physical Illnesses and Quality of Life
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hemodialysis
Hemodialysis patients
|
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
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 years
|
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.
|
3 years
|
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. |
3 years
|
Fatigue symptoms
Time Frame: 3 years
|
Fatigue symptoms will be evaluated using the self-reported Fatigue Scale.
|
3 years
|
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.
|
3 years
|
Genotyping
Time Frame: 3 years
|
The Genomic DNA will be extracted from peripheral blood by standard methods.
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chih-Ken Chen, MD, PhD, Chang Gung Memorial Hospital
Publications and helpful links
General Publications
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- Heils A, Teufel A, Petri S, Stober G, Riederer P, Bengel D, Lesch KP. Allelic variation of human serotonin transporter gene expression. J Neurochem. 1996 Jun;66(6):2621-4. doi: 10.1046/j.1471-4159.1996.66062621.x.
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- Kuo WH, Gallo JJ, Tien AY. Incidence of suicide ideation and attempts in adults: the 13-year follow-up of a community sample in Baltimore, Maryland. Psychol Med. 2001 Oct;31(7):1181-91. doi: 10.1017/s0033291701004482.
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- Maes M, Vandoolaeghe E, Ranjan R, Bosmans E, Bergmans R, Desnyder R. Increased serum interleukin-1-receptor-antagonist concentrations in major depression. J Affect Disord. 1995 Dec 24;36(1-2):29-36. doi: 10.1016/0165-0327(95)00049-6.
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- Miller DB, O'Callaghan JP. Depression, cytokines, and glial function. Metabolism. 2005 May;54(5 Suppl 1):33-8. doi: 10.1016/j.metabol.2005.01.011.
- Nakamura M, Ueno S, Sano A, Tanabe H. The human serotonin transporter gene linked polymorphism (5-HTTLPR) shows ten novel allelic variants. Mol Psychiatry. 2000 Jan;5(1):32-8. doi: 10.1038/sj.mp.4000698.
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- Perlman RL, Finkelstein FO, Liu L, Roys E, Kiser M, Eisele G, Burrows-Hudson S, Messana JM, Levin N, Rajagopalan S, Port FK, Wolfe RA, Saran R. Quality of life in chronic kidney disease (CKD): a cross-sectional analysis in the Renal Research Institute-CKD study. Am J Kidney Dis. 2005 Apr;45(4):658-66. doi: 10.1053/j.ajkd.2004.12.021.
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- Sakai K, Nakamura M, Ueno S, Sano A, Sakai N, Shirai Y, Saito N. The silencer activity of the novel human serotonin transporter linked polymorphic regions. Neurosci Lett. 2002 Jul 12;327(1):13-6. doi: 10.1016/s0304-3940(02)00348-8.
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- Weissman MM, Gershon ES, Kidd KK, Prusoff BA, Leckman JF, Dibble E, Hamovit J, Thompson WD, Pauls DL, Guroff JJ. Psychiatric disorders in the relatives of probands with affective disorders. The Yale University--National Institute of Mental Health Collaborative Study. Arch Gen Psychiatry. 1984 Jan;41(1):13-21. doi: 10.1001/archpsyc.1984.01790120015003.
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- Wang LJ, Chen SW, Chen CK, Yen CL, Chang JJ, Lee TS, Liu CJ, Chen LW, Chien RN. Treatment-emergent depression and anxiety between peginterferon alpha-2a versus alpha-2b plus ribavirin for chronic hepatitis C. BMC Psychiatry. 2016 Nov 25;16(1):424. doi: 10.1186/s12888-016-1135-8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98-2314-B-182-023-MY3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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