NCT06293534

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

December 13, 2023

Last Update Submit

February 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • the level of thyroid hormones among psychiatric patients

    TSH, free T3 and free T4 levels in psychiatric patients.

    One year

Study Arms (1)

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

Interventions

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

Patients with major psychiatric disorders

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 23449617BACKGROUND
  • 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.

    PMID: 36811059BACKGROUND
  • 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.

    PMID: 22318794BACKGROUND
  • 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.

    PMID: 11722306BACKGROUND
  • 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.

    PMID: 24521631BACKGROUND
  • 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.

    PMID: 31763175BACKGROUND

Study Officials

  • Ghada Abdelrahman mohamed, M.D.

    Assiut University

    STUDY DIRECTOR
  • Rania Mohamed Mahmoud Hafez, M.D.

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 13, 2023

First Posted

March 5, 2024

Study Start

March 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

March 5, 2024

Record last verified: 2024-02