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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Observe the relationship between thyroid function and personality traits

Condition or disease Intervention/treatment
Graves' Disease Procedure: blood sampling

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Group/Cohort Intervention/treatment
Graves' disease
Patient had been diagnosed of Graves' disease and now under euthyroid status
Procedure: blood sampling
blood sampling




Primary Outcome Measures :
  1. 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
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Shyang-Rong Shih, Doctor 886-972653337 srshih@ntu.edu.tw

Locations
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Taiwan
Shyang-Rong Shih Recruiting
Taipei, Taiwan, 100
Contact: Shyang-Rong Shih    886-972653337    srshih@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Shyang-Rong Shih, Doctor National Taiwan University Hospital

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02620085     History of Changes
Other Study ID Numbers: 201107013RC
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by National Taiwan University Hospital:
Graves' disease
Hyperthyroidism
Personality traits
Additional relevant MeSH terms:
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Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases