Graves' DiseaseTPSNCT02620085
Thyroid Disease and Personality Study
An observational study of Graves' Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Observe the relationship between thyroid function and personality traits Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Graves' Disease
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- aged between 20 and 85 years
- euthyroid Graves' disease
Who cannot join
- Patients who were not capable to complete the questionnaire due to severe cognitive dysfunction or under education were excluded from this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shyang-Rong Shih
Taipei, Taiwan, 100
Shyang-Rong Shih, 886-972653337, srshih@ntu.edu.tw
About this study
Official title: Bio-psycho-social Correlates of Psychological Distress in Patients With Graves' Disease in Euthyroid Status
Observe the relationship between thyroid function and personality traits
Read the detailed description
Thyrotoxicosis was the biochemical and physiological manifestations of excess thyroid hormone. The clinical manifestation was palpitation, heat intolerance, hand tremor, and weight loss. The clinical manifestation also included nervous system, including anxiety, tension, irritability, hyperactivity, fatigue, and insomnia.
Where tensions features include restless, short attention span, and the impulse to want to move around. Some patients will progress to a non-specific psychiatric disorders. According to the study, about 10% of patients will occur very frank psychosis, 3, 31% to 69% of patients with depressive symptoms, 61% to 62% of patients with symptoms of anxiety.
Some studies using reliable evaluation tool to evaluate behavioral changes in patients with thyrotoxicosis, such as Clyde emotional scale, multi-faceted personality assessment table (Multiphasic Personality Inventory (MMPI)), or observation of a response time to visual or audio stimulation. After treatment of thyrotoxicosis, most of these indicators have improved, but some indicators were still abnormal after treatment of thyrotoxicosis, such as MMPI and voice response time.
The physiological causes of the changes of these nervous system is not clear. The symptoms was improved after the use of sympathetic inhibitors, so presumably this may correlated with autonomic nervous system disorders.
Thyroid hormone receptors are widely distributed in the brain may also be one of the cause. But there still some other reasons for the changes of neurological symptoms because neurological symptoms may not be back to normal even after thyroid function returned to normal. Autoimmune dysfunction affect brain function may be the most possible reason. Graves' disease is the most common cause of thyrotoxicosis and it is related to autoimmune thyroid antibodies.
Clinically, some patients of Graves' disease may combined with other autoimmune disease, such as Sicca syndrome. The patient may still have nervous personality traits despite normalized thyroid function. Some patients even need long-term use of anti-anxiety medication.
In this study, investigators hope to analyze the personality traits of patients with hyperthyroidism,especially patients of Graves' disease, in Taiwan and to observe the changes during treatment. Investigators also hope to observe the statistical change of other non-thyroid-specific autoimmune index in this thyrotoxicosis patient. After obtaining these results, investigators will evaluate whether to continue to study the hypothesis of affection of brain of thyrotoxic patients by the abnormal autoimmune system.
- Conditions
- Graves' Disease
- Being tested
- blood sampling
- Keywords
- Graves' disease, Hyperthyroidism, Personality traits
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Graves' disease | Patient had been diagnosed of Graves' disease and now under euthyroid status Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJul 2011
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyang-Rong Shih, Doctor, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620085
- Sponsor's protocol ID
- 201107013RC
- Acronym
- TPS
- Status last verified
- Nov 2015
- First submitted
- 4 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3943712Trzepacz 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.
PubMed 3345907BURSTEN B. Psychoses associated with thyrotoxicosis. Arch Gen Psychiatry. 1961 Mar;4:267-73. doi: 10.1001/archpsyc.1961.01710090053007. No abstract available.
PubMed 13689243Lee 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.
PubMed 1982678Lee 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.
PubMed 16704526Liao 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.
PubMed 14747634Chen 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.
PubMed 20978017Hsu 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.
PubMed 19532128Derogatis 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.
PubMed 4682398Liao 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.
PubMed 12051011Lee MB, Rin H, Lin HN, Lee YJ Personality as an effective predictor of outcome for neurotic disorders. Chinese Psychiatry 1990; 4:111-121.
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.
PubMed 13641975EYSENCK HJ. Personality. Annu Rev Psychol. 1952;3:151-74. doi: 10.1146/annurev.ps.03.020152.001055. No abstract available.
PubMed 12977189Smilkstein 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.
PubMed 7097168Schreckenberger 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.
PubMed 16968792
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-psycho-social Correlates of Psychological Distress in Patients With Graves' Disease in Euthyroid Status
- ClinicalTrials.gov ID
- NCT02620085
- Acronym / sponsor ID
- TPS / 201107013RC
- Conditions
- Graves' Disease
- Keywords
- Graves' disease, Hyperthyroidism, Personality traits
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observe the relationship between thyroid function and personality traits
Detailed description
Thyrotoxicosis was the biochemical and physiological manifestations of excess thyroid hormone. The clinical manifestation was palpitation, heat intolerance, hand tremor, and weight loss. The clinical manifestation also included nervous system, including anxiety, tension, irritability, hyperactivity, fatigue, and insomnia.
Where tensions features include restless, short attention span, and the impulse to want to move around. Some patients will progress to a non-specific psychiatric disorders. According to the study, about 10% of patients will occur very frank psychosis, 3, 31% to 69% of patients with depressive symptoms, 61% to 62% of patients with symptoms of anxiety.
Some studies using reliable evaluation tool to evaluate behavioral changes in patients with thyrotoxicosis, such as Clyde emotional scale, multi-faceted personality assessment table (Multiphasic Personality Inventory (MMPI)), or observation of a response time to visual or audio stimulation. After treatment of thyrotoxicosis, most of these indicators have improved, but some indicators were still abnormal after treatment of thyrotoxicosis, such as MMPI and voice response time.
The physiological causes of the changes of these nervous system is not clear. The symptoms was improved after the use of sympathetic inhibitors, so presumably this may correlated with autonomic nervous system disorders.
Thyroid hormone receptors are widely distributed in the brain may also be one of the cause. But there still some other reasons for the changes of neurological symptoms because neurological symptoms may not be back to normal even after thyroid function returned to normal. Autoimmune dysfunction affect brain function may be the most possible reason. Graves' disease is the most common cause of thyrotoxicosis and it is related to autoimmune thyroid antibodies.
Clinically, some patients of Graves' disease may combined with other autoimmune disease, such as Sicca syndrome. The patient may still have nervous personality traits despite normalized thyroid function. Some patients even need long-term use of anti-anxiety medication.
In this study, investigators hope to analyze the personality traits of patients with hyperthyroidism,especially patients of Graves' disease, in Taiwan and to observe the changes during treatment. Investigators also hope to observe the statistical change of other non-thyroid-specific autoimmune index in this thyrotoxicosis patient. After obtaining these results, investigators will evaluate whether to continue to study the hypothesis of affection of brain of thyrotoxic patients by the abnormal autoimmune system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Graves' disease | – | Procedure: blood samplingPatient had been diagnosed of Graves' disease and now under euthyroid status |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- aged between 20 and 85 years
- euthyroid Graves' disease
Key exclusion criteria (1 listed)
- Patients who were not capable to complete the questionnaire due to severe cognitive dysfunction or under education were excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood sampling | Procedure or surgery | Graves' disease |
Primary outcome
Psychological distress in scores measured using the Brief Symptom Rating Scale
Time frame: Within one year after inclusion
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 3943712Kathol 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.
- Background: PubMed 3345907Trzepacz 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.
- Background: PubMed 13689243BURSTEN B. Psychoses associated with thyrotoxicosis. Arch Gen Psychiatry. 1961 Mar;4:267-73. doi: 10.1001/archpsyc.1961.01710090053007. No abstract available.
- Background: PubMed 1982678Lee 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.
- Background: PubMed 16704526Lee 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.
- Background: PubMed 14747634Liao 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.
- Background: PubMed 20978017Chen 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.
- Background: PubMed 19532128Hsu 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.
- Background: PubMed 4682398Derogatis 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.
- Background: PubMed 12051011Liao 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.
- BackgroundLee MB, Rin H, Lin HN, Lee YJ Personality as an effective predictor of outcome for neurotic disorders. Chinese Psychiatry 1990; 4:111-121.
- Background: PubMed 13641975BARTHOLOMEW 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyang-Rong Shih, Doctor study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves' Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shyang-Rong Shih, Doctor (886-972653337, srshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress in scores measured using the Brief Symptom Rating Scale (time frame: Within one year after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620085, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.