- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06293534
Thyroid Dysfunction in Patients With Major Psychiatric Disorders
February 27, 2024 updated by: Marwa Mahmoud Abdelsalam, Assiut University
Thyroid Dysfunction in Patient With Major Psychiatric Disorders Admitted to Psychiatric Unit of Assiut University Hospital
Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
173
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marwa M Abdelsalam
- Phone Number: +201018987436
- Email: marwamahmouud.97@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the level of thyroid hormones among psychiatric patients
Time Frame: One year
|
TSH, free T3 and free T4 levels in psychiatric patients.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ghada Abdelrahman mohamed, M.D., Assiut University
- Study Director: Rania Mohamed Mahmoud Hafez, M.D., Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kamble MT, Nandedkar PD, Dharme PV, L LS, Bhosale PG. Thyroid function and mental disorders: an insight into the complex interaction. J Clin Diagn Res. 2013 Jan;7(1):11-4. doi: 10.7860/JCDR/2012/4861.2656. Epub 2013 Jan 1.
- Lekurwale V, Acharya S, Shukla S, Kumar S. Neuropsychiatric Manifestations of Thyroid Diseases. Cureus. 2023 Jan 20;15(1):e33987. doi: 10.7759/cureus.33987. eCollection 2023 Jan.
- Dickerman AL, Barnhill JW. Abnormal thyroid function tests in psychiatric patients: a red herring? Am J Psychiatry. 2012 Feb;169(2):127-33. doi: 10.1176/appi.ajp.2011.11040631.
- Lederbogen F, Hermann D, Hewer W, Henn FA. Thyroid function test abnormalities in newly admitted psychiatric patients residing in an iodine-deficient area: patterns and clinical significance. Acta Psychiatr Scand. 2001 Oct;104(4):305-10. doi: 10.1034/j.1600-0447.2001.00328.x.
- Radhakrishnan R, Calvin S, Singh JK, Thomas B, Srinivasan K. Thyroid dysfunction in major psychiatric disorders in a hospital based sample. Indian J Med Res. 2013 Dec;138(6):888-93.
- Fukao A, Takamatsu J, Arishima T, Tanaka M, Kawai T, Okamoto Y, Miyauchi A, Imagawa A. Graves' disease and mental disorders. J Clin Transl Endocrinol. 2019 Oct 11;19:100207. doi: 10.1016/j.jcte.2019.100207. eCollection 2020 Mar.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
December 13, 2023
First Submitted That Met QC Criteria
February 27, 2024
First Posted (Estimated)
March 5, 2024
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PsychThyroid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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