NCT02620085

Brief Summary

Observe the relationship between thyroid function and personality traits

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

10 years

First QC Date

November 4, 2015

Last Update Submit

December 1, 2015

Conditions

Graves' Disease

Keywords

Graves' diseaseHyperthyroidismPersonality traits

Outcome Measures

Primary Outcomes (1)

  • Psychological distress in scores measured using the Brief Symptom Rating Scale

    Psychological distress is measured by using the Brief Symptom Rating Scale (BSRS). The BSRS is a self-report questionnaire with 30 items rated from 0 to 4 scores on the basis of the degree of distress. BSRS covers nine dimensions of psychopathology: somatization, obsessive-compulsive disorder, interpersonal sensitivity, depression, anxiety, hostility, phobic-anxiety, paranoid ideation, and additional symptoms.

    Within one year after inclusion

Study Arms (1)

Graves' disease

Patient had been diagnosed of Graves' disease and now under euthyroid status

Procedure: blood sampling

Interventions

blood samplingPROCEDURE

blood sampling

Graves' disease

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients were aged between 20 and 85 years and fulfilled the criteria for euthyroid GD. GD is defined by a history of hyperthyroidism, thyroid eye disease or pretibial myxedema with abnormal high thyroglobulin binding immunoglobulin (TBII) level and autoimmune characteristics on thyroid echography. Euthyroidism is defined by normal free thyroxine (fT4) and thyrotropin (TSH) level.

You may qualify if:

  • aged between 20 and 85 years
  • euthyroid Graves' disease

You may not qualify if:

  • Patients who were not capable to complete the questionnaire due to severe cognitive dysfunction or under education were excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shyang-Rong Shih

Taipei, Taiwan, 100, Taiwan

RECRUITING

Related Publications (19)

  • Kathol RG, Delahunt JW. The relationship of anxiety and depression to symptoms of hyperthyroidism using operational criteria. Gen Hosp Psychiatry. 1986 Jan;8(1):23-8. doi: 10.1016/0163-8343(86)90060-5.

    PMID: 3943712BACKGROUND

  • Trzepacz PT, McCue M, Klein I, Levey GS, Greenhouse J. A psychiatric and neuropsychological study of patients with untreated Graves' disease. Gen Hosp Psychiatry. 1988 Jan;10(1):49-55. doi: 10.1016/0163-8343(88)90084-9.

    PMID: 3345907BACKGROUND

  • BURSTEN B. Psychoses associated with thyrotoxicosis. Arch Gen Psychiatry. 1961 Mar;4:267-73. doi: 10.1001/archpsyc.1961.01710090053007. No abstract available.

    PMID: 13689243BACKGROUND

  • Lee MB, Lee YJ, Yen LL, Lin MH, Lue BH. Reliability and validity of using a Brief Psychiatric Symptom Rating Scale in clinical practice. J Formos Med Assoc. 1990 Dec;89(12):1081-7.

    PMID: 1982678BACKGROUND

  • Lee YC, Wang HP, Chiu HM, Liao SC, Huang SP, Lai YP, Wu MS, Chen MF, Lin JT. Comparative analysis between psychological and endoscopic profiles in patients with gastroesophageal reflux disease: a prospective study based on screening endoscopy. J Gastroenterol Hepatol. 2006 May;21(5):798-804. doi: 10.1111/j.1440-1746.2005.04034.x.

    PMID: 16704526BACKGROUND

  • Liao SC, Lee MB, Lee YJ, Huang TS. Hyperleptinemia in subjects with persistent partial posttraumatic stress disorder after a major earthquake. Psychosom Med. 2004 Jan-Feb;66(1):23-8. doi: 10.1097/01.psy.0000106880.22867.0e.

    PMID: 14747634BACKGROUND

  • Chen CA, Liao SC, Wang JK, Chang CI, Chiu IS, Chen YS, Lu CW, Lin MT, Chiu HH, Chiu SN, Hua YC, Lue HC, Wu MH. Quality of life in adults with congenital heart disease: biopsychosocial determinants and sex-related differences. Heart. 2011 Jan;97(1):38-43. doi: 10.1136/hrt.2010.200709. Epub 2010 Oct 26.

    PMID: 20978017BACKGROUND

  • Hsu YC, Liou JM, Liao SC, Yang TH, Wu HT, Hsu WL, Lin HJ, Wang HP, Wu MS. Psychopathology and personality trait in subgroups of functional dyspepsia based on Rome III criteria. Am J Gastroenterol. 2009 Oct;104(10):2534-42. doi: 10.1038/ajg.2009.328. Epub 2009 Jun 16.

    PMID: 19532128BACKGROUND

  • Derogatis LR, Lipman RS, Covi L. SCL-90: an outpatient psychiatric rating scale--preliminary report. Psychopharmacol Bull. 1973 Jan;9(1):13-28. No abstract available.

    PMID: 4682398BACKGROUND

  • Liao SC, Lee MB, Lee YJ, Weng T, Shih FY, Ma MH. Association of psychological distress with psychological factors in rescue workers within two months after a major earthquake. J Formos Med Assoc. 2002 Mar;101(3):169-76.

    PMID: 12051011BACKGROUND

  • Lee MB, Rin H, Lin HN, Lee YJ Personality as an effective predictor of outcome for neurotic disorders. Chinese Psychiatry 1990; 4:111-121.

    BACKGROUND

  • BARTHOLOMEW AA, MARLEY E. The temporal reliability of the Maudsley personality inventory. J Ment Sci. 1959 Jan;105(438):238-40. doi: 10.1192/bjp.105.438.238. No abstract available.

    PMID: 13641975BACKGROUND

  • EYSENCK HJ. Personality. Annu Rev Psychol. 1952;3:151-74. doi: 10.1146/annurev.ps.03.020152.001055. No abstract available.

    PMID: 12977189BACKGROUND

  • Smilkstein G, Ashworth C, Montano D. Validity and reliability of the family APGAR as a test of family function. J Fam Pract. 1982 Aug;15(2):303-11.

    PMID: 7097168BACKGROUND

  • Schreckenberger MF, Egle UT, Drecker S, Buchholz HG, Weber MM, Bartenstein P, Kahaly GJ. Positron emission tomography reveals correlations between brain metabolism and mood changes in hyperthyroidism. J Clin Endocrinol Metab. 2006 Dec;91(12):4786-91. doi: 10.1210/jc.2006-0573. Epub 2006 Sep 12.

    PMID: 16968792BACKGROUND

  • Jaracz J, Kucharska A, Rajewska-Rager A, Lacka K. Cognitive functions and mood during chronic thyrotropin-suppressive therapy with L-thyroxine in patients with differentiated thyroid carcinoma. J Endocrinol Invest. 2012 Sep;35(8):760-5. doi: 10.3275/8013. Epub 2011 Oct 6.

    PMID: 21986400BACKGROUND

  • Boelaert K, Newby PR, Simmonds MJ, Holder RL, Carr-Smith JD, Heward JM, Manji N, Allahabadia A, Armitage M, Chatterjee KV, Lazarus JH, Pearce SH, Vaidya B, Gough SC, Franklyn JA. Prevalence and relative risk of other autoimmune diseases in subjects with autoimmune thyroid disease. Am J Med. 2010 Feb;123(2):183.e1-9. doi: 10.1016/j.amjmed.2009.06.030.

    PMID: 20103030BACKGROUND

  • Kirshner HS. Hashimoto's encephalopathy: a brief review. Curr Neurol Neurosci Rep. 2014 Sep;14(9):476. doi: 10.1007/s11910-014-0476-2.

    PMID: 25027262BACKGROUND

  • Lin CH, Chang CK, Shih CW, Li HY, Chen KY, Yang WS, Tsai KS, Wang CY, Shih SR. Serum fibroblast growth factor 23 and mineral metabolism in patients with euthyroid Graves' diseases: a case-control study. Osteoporos Int. 2019 Nov;30(11):2289-2297. doi: 10.1007/s00198-019-05116-1. Epub 2019 Aug 5.

    PMID: 31384956DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Graves DiseaseHyperthyroidism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Shyang-Rong Shih, Doctor

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Shyang-Rong Shih, Doctor

CONTACT

886-972653337srshih@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

December 2, 2015

Study Start

July 1, 2011

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

TW(1)