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Thyroid Dysfunction in Patients With Major Psychiatric Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT06293534
Recruitment Status : Not yet recruiting
First Posted : March 5, 2024
Last Update Posted : March 5, 2024
Information provided by (Responsible Party):
Marwa Mahmoud Abdelsalam, Assiut University

Brief Summary:
Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital

Condition or disease Intervention/treatment
Thyroid Dysfunction Diagnostic Test: TSH,T3,T4

Detailed Description:
Thyroid hormones play a key role in the development, metabolism and functioning of many organs and have a profound influence on the human brain and behaviour. the coexistence of thyroid insufficiency with mental disorders was recognized . Mental disorders accounted for 6 of the 20 leading causes of disability worldwide for the most productive section of the population.Thyroid diseases can present with various neuropsychiatric manifestations which include mood, anxiety, psychotic, and cognitive disorders.Thus, thyroid function tests are routinely checked in psychiatric patients, While dealing with neurocognitive or neuropsychiatric manifestations,thyroid disorders should be ruled out by appropriate thyroid function tests which include Thyroid-stimulating hormone (TSH), free T3, free T4 and reverse T3.Multiple studies on the prevalence of thyroid dysfunctions on psychiatric patients in different populations were done and reported .the presence of thyroid dysfunction in patients with schizophrenia-spectrum disorder as well as mood disorders .Mental disorders merge highly with thyroid disease.Bio-psycho-social medical model are important for treatment of mental disorders associated with thyroid dysfunction .Till now, there is no literature on the rates of thyroid dysfunction among psychiatric patient in our population in assiut university hospital which can be helpful in the proper management of the cases.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 173 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Thyroid Dysfunction in Patient With Major Psychiatric Disorders Admitted to Psychiatric Unit of Assiut University Hospital
Estimated Study Start Date : March 1, 2024
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
Patients with major psychiatric disorders
Patients diagnosed with major psychiatric disorders according to the Diagnostic Statistical Manual version 5 (DSM 5-TR), admitted to the psychiatry department in Assiut University Hospital.
Diagnostic Test: TSH,T3,T4
Diagnosis of the psychiatric disorders among study group will be assessed and recorded and history of Electroconvulsive therapy (ECT) also will be recorded , physical examination for signs that suggests actual thyroid disease such as unexplained bradycardia or tachycardia, hypothermia , goiter or non palpable thyroid among study group will be assessed

Primary Outcome Measures :
  1. the level of thyroid hormones among psychiatric patients [ Time Frame: One year ]
    TSH, free T3 and free T4 levels in psychiatric patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with mental illness, diagnosed based on DSM 5-TR and whose condition is severe enough to require admission in the psychiatric ward.

Inclusion Criteria:

  • patients with major psychiatric disorders admitted to psychiatric unit of neuropsychiatry department of Assiut university hospital in Egypt.

Exclusion Criteria:

  • pregnant or lactating females
  • Patients on estrogen therapy or contraceptive
  • Patients on carbamazepine, oxcarbazepine, phenytoin

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 identifier (NCT number): NCT06293534

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Contact: Marwa M Abdelsalam +201018987436

Sponsors and Collaborators
Assiut University
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Study Director: Ghada Abdelrahman mohamed, M.D. Assiut University
Study Director: Rania Mohamed Mahmoud Hafez, M.D. Assiut University
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Responsible Party: Marwa Mahmoud Abdelsalam, Principle Investigator, Assiut University Identifier: NCT06293534    
Other Study ID Numbers: PsychThyroid
First Posted: March 5, 2024    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Diseases
Mental Disorders
Problem Behavior
Endocrine System Diseases
Behavioral Symptoms