Thyroid Disease and Personality Study

Graves' Disease Clinical Trial

— TPS  

Official title:

Bio-psycho-social Correlates of Psychological Distress in Patients With Graves' Disease in Euthyroid Status

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02620085
• Other study ID #: 201107013RC
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2015
• Last updated: December 1, 2015
• Start date: July 2011
• Est. completion date: July 2021

Study information

• Verified date: November 2015
• Source: National Taiwan University Hospital
• Contact: Shyang-Rong Shih, Doctor
• Phone: 886-972653337
• Email: srshih[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

Observe the relationship between thyroid function and personality traits

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• aged between 20 and 85 years

• euthyroid Graves' disease

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Graves Disease
• Graves' Disease

Intervention

Procedure:
• blood sampling
blood sampling

Locations

Country	Name	City	State
Taiwan	Shyang-Rong Shih	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (18)

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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. Epub 2006 Sep 12. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No