Clinical trial NCT02620085: Thyroid Disease and Personality Study
Official title: Bio-psycho-social Correlates of Psychological Distress in Patients With Graves' Disease in Euthyroid Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graves' Disease
Keywords: Graves' disease
Hyperthyroidism
Personality traits
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychological distress in scores measured using the Brief Symptom Rating Scale
timeFrame: Within one year after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shyang-Rong Shih
Study officials:
affiliation: National Taiwan University Hospital
name: Shyang-Rong Shih, Doctor
role: STUDY_DIRECTOR
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