Thyroid DysfunctionNCT06293534
Thyroid Dysfunction in Patients With Major Psychiatric Disorders
An observational study of Thyroid Dysfunction, run by Assiut University.
Trial summary
Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Dysfunction
- What is being tested?
- TSH,T3,T4
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Feb 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with major psychiatric disorders admitted to psychiatric unit of neuropsychiatry department of Assiut university hospital in Egypt.
Who cannot join
- pregnant or lactating females
- Patients on estrogen therapy or contraceptive
- Patients on carbamazepine, oxcarbazepine, phenytoin
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Thyroid Dysfunction
- Being tested
- TSH,T3,T4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSH,T3,T4Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: TSH,T3,T4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of thyroid hormones among psychiatric patients
TSH, free T3 and free T4 levels in psychiatric patients.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thyroid DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 173 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mahmoud Abdelsalam, Assiut University
- Investigators
- Ghada Abdelrahman mohamed, M.D., Study director, Assiut UniversityRania Mohamed Mahmoud Hafez, M.D., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293534
- Sponsor's protocol ID
- PsychThyroid
- Status last verified
- Feb 2024
- First submitted
- 13 Dec 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23449617Lekurwale 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.
PubMed 36811059Dickerman 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.
PubMed 22318794Lederbogen 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.
PubMed 11722306Radhakrishnan 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.
PubMed 24521631Fukao 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.
PubMed 31763175
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Dysfunction in Patient With Major Psychiatric Disorders Admitted to Psychiatric Unit of Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06293534
- Acronym / sponsor ID
- PsychThyroid
- Conditions
- Thyroid Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with major psychiatric disorders | – | Diagnostic Test: TSH,T3,T4Patients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with major psychiatric disorders admitted to psychiatric unit of neuropsychiatry department of Assiut university hospital in Egypt.
Key exclusion criteria (3 listed)
- pregnant or lactating females
- Patients on estrogen therapy or contraceptive
- Patients on carbamazepine, oxcarbazepine, phenytoin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSH,T3,T4Diagnosis 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 | Diagnostic test | Patients with major psychiatric disorders |
Primary outcome
the level of thyroid hormones among psychiatric patients
Time frame: One year
TSH, free T3 and free T4 levels in psychiatric patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 23449617Kamble 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.
- Background: PubMed 36811059Lekurwale 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.
- Background: PubMed 22318794Dickerman 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.
- Background: PubMed 11722306Lederbogen 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.
- Background: PubMed 24521631Radhakrishnan 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.
- Background: PubMed 31763175Fukao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada Abdelrahman mohamed, M.D. study director
Assiut University
Rania Mohamed Mahmoud Hafez, M.D. study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Dysfunction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa M Abdelsalam (+201018987436, marwamahmouud.97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of thyroid hormones among psychiatric patients (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06293534, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.