Thyroid Disease and Personality Study (TPS)
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|ClinicalTrials.gov Identifier: NCT02620085|
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment|
|Graves' Disease||Procedure: blood sampling|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Bio-psycho-social Correlates of Psychological Distress in Patients With Graves' Disease in Euthyroid Status|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Patient had been diagnosed of Graves' disease and now under euthyroid status
Procedure: blood sampling
- 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620085
|Contact: Shyang-Rong Shih, Doctoremail@example.com|
|Taipei, Taiwan, 100|
|Contact: Shyang-Rong Shih 886-972653337 firstname.lastname@example.org|
|Study Director:||Shyang-Rong Shih, Doctor||National Taiwan University Hospital|