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Hypothyroidism PrimaryNCT06660888

Study of Chronic Fatigue, Depression, and Anxiety Among Hypothyroid Patients Attending Assuit University Hospitals

An observational study of Hypothyroidism Primary, run by Assiut University at 1 site in Egypt.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Assessment of the prevalence of chronic fatigue, depression, and anxiety among patients with hypothyroidism in Assuit University Hospital. Assess the severity of chronic fatigue, depression, and anxiety according to the duration and control of treatment in patients with hypothyroidism. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hypothyroidism Primary
What is being tested?
• Fatigue Severity Scale (FFS). • Hamilton Rating Scale for Depression (HRSD-17). • Hamilton Anxiety Rating Scale (HAM-A).
How many people
406 participants
Where
1 siteEgypt
Study dates
27 Jan 2025to Dec 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients diagnosed with primary hypothyroidism with age from 18 to 60 years.

Who may be able to join

  • Patients diagnosed with primary hypothyroidism.
  • Age from 18 to 60 years.

Who cannot join

  • Patients who were previously diagnosed with any psychiatric diseases.
  • Serious and chronic diseases (e.g. anemia, liver, heart or kidney problems).
  • consumption of medications that may interfere with thyroid function (e.g., chemotherapy), patients who had a history of any type of cancer, due to the confounding effects of cancer on fatigue as the outcome of interest.
  • Women who were pregnant or had given birth in the last 6 months to exclude postpartum thyroiditis and depression.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site

  • Assuit university hospitals

    Asyut, Assuit

Other trials in Egypt

About this study

  • Assessment of the prevalence of chronic fatigue, depression, and anxiety among patients with hypothyroidism in Assuit University Hospital.
  • Assess the severity of chronic fatigue, depression, and anxiety according to the duration and control of treatment in patients with hypothyroidism.
Read the detailed description

Hypothyroidism is a prevalent endocrine illness with a global impact, necessitating treatment in extreme instances. Inadequate management of hypothyroidism has been associated with adverse health outcomes, including neurological and musculoskeletal issues,this condition impacting approximately 1-6% of the general population.

Thyroid hormone is essential for the normal development of many human tissues and regulates the metabolism of virtually all cells and organs of the human body throughout life. Overt hypothyroidism is defined by thyroid-stimulating hormone (TSH) levels above the upper limit of the reference range, while levels of free thyroxine (fT4) are below the lower limit of the reference range. The reference range is typically statistically defined by the 2.5th and 97.5th percentiles of the measured circulating thyroid hormone values in populations defined as healthy.

It has been reported that up to one-third of patients presenting with fatigue have thyroid disease, predominantly in women,and fatigue was the most common noted symptom among patients with hypothyroidism.Also patients with thyroid disorders are more prone to developing depressive symptoms.

There are few previous studies that addressed this topic in the Egyptian population.

Being tested
• Fatigue Severity Scale (FFS). • Hamilton Rating Scale for Depression (HRSD-17). • Hamilton Anxiety Rating Scale (HAM-A).
Keywords
Fatigue, Depression, Anxiety
Medical subject headings
Hypothyroidism, Fatigue, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • • Fatigue Severity Scale (FFS). • Hamilton Rating Scale for Depression (HRSD-17). • Hamilton Anxiety Rating Scale (HAM-A).Behavioural

    1. Fatigue Severity Scale The FSS is one of the most commonly used fatigue questionnaires in chronic diseases. It measures how fatigue affects motivation, exercise, physical functioning, carrying out duties, work, family, or social life.
    2. Hamilton Depression Rating Scale The 17-item Hamilton Depression Rating Scale (HRSD-17) is the most popular depression measure in antidepressant clinical trials.
    3. Hamilton Anxiety Rating Scale The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of chronic fatigue in patients with hypothyroidism at Assuit University Hospitals.

    Prevelance of fatigue will be assessd by fatigue severity scale, this scale consists of nine items, each item consists of statements that are scored on a seven-point Likert type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The minimum score is 9 and the maximum score possible is 63. Higher the score = greater fatigue severity.

    The scores are averaged across the nine statements, and a score ≥36 indicates a clinically significant trait level of fatigue.

    Measured: Baseline

  2. Prevalence of depression in patients with hypothyroidism at Assuit University Hospitals.

    Prevalence of depression will be assessed by Hamilton Rating Scale for Depression ,it consists of 17 items, each of them is rated on a 0-4 scale, except for items 10 (sleep disorders) and 14 (somatic symptoms), which are rated on a 0-2 scale. The scores are interpreted as follows :

    HAM-D score 7-17: mild depression; HAM-D score 18-24: moderate depression; and HAM-D score 25 or higher: severe depression

    Measured: Baseline

  3. Prevalence of anxiety in patients with hypothyroidism at Assuit University Hospitals.

    Prevalence of anxiety will be assessed by Hamilton Rating Scale of Anxiety, The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).

    Each item is scored on a scale of 0 (not present) to 4 (very severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

    Measured: Baseline

Secondary outcomes (3)

  1. Compare the severity of chronic fatigue according to the duration and control of treatment in patients with hypothyroidism.

    By using the Fatigue Severity Scale with the minimum score is 9 and the maximum score possible is 63. The higher the score the greater fatigue severity.

    We will compare the severity of fatigue to the duration of levothyroxine treatment and if there is improvement of fatigue severity in hypothyroidism patients with good control of treatment or not.

    Measured: Baseline

  2. Compare the severity of depression according to the duration and control of treatment in patients with hypothyroidism.

    By using the Hamilton Depression Rating Scale with the following scores; HAM-D score 7-17: mild depression; HAM-D score 18-24: moderate depression; and HAM-D score 25 or higher: severe depression. We will compare the relationship between the severity of depression and the duration and control of levothyroxine treatment in hypothyroid patients.

    We will compare if there is improvement of the severity of depression with good control of treatment or not.

    Measured: Baseline

  3. Compare the severity of anxiety according to the duration and control of treatment in patients with hypothyroidism.

    By using the Hamilton Anxiety Rating Scale with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. We will compare the relationship between the severity of anxiety and the duration of levothyroxine treatment in hypothyroid patients and if there is improvement of anxiety with good control of treatment or not.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start27 Jan 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
406 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660888
Sponsor's protocol ID
Fatigue in Hypothyroidism
Status last verified
Oct 2024
First submitted
10 Oct 2024
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Udovcic M, Pena RH, Patham B, Tabatabai L, Kansara A. Hypothyroidism and the Heart. Methodist Debakey Cardiovasc J. 2017 Apr-Jun;13(2):55-59. doi: 10.14797/mdcj-13-2-55.

    PubMed 28740582

  • Sethi B, Barua S, Raghavendra MS, Gotur J, Khandelwal D, Vyas U. The Thyroid Registry: Clinical and Hormonal Characteristics of Adult Indian Patients with Hypothyroidism. Indian J Endocrinol Metab. 2017 Mar-Apr;21(2):302-307. doi: 10.4103/ijem.IJEM_387_16.

    PubMed 28459030

  • Evans KM, Flanagan DE, Wilkin TJ. Chronic fatigue: is it endocrinology? Clin Med (Lond). 2009 Feb;9(1):34-8. doi: 10.7861/clinmedicine.9-1-34.

    PubMed 19271598

  • Ruiz-Pacheco MG, Hernandez I, Hernandez-Estrella G, Basurto L, Vargas-Ortega G, Gonzalez-Virla B, Molina-Ayala M, Hernandez-Martinez AF, Luengas-Mondragon R, Hernandez-Allende AA, Mendoza-Zubieta V, Balcazar-Hernandez L. Severity of Fatigue and Its Relationship with TSH before and after Levothyroxine Replacement Therapy in Patients with Primary Hypothyroidism. Biomedicines. 2023 Mar 7;11(3):811. doi: 10.3390/biomedicines11030811.

    PubMed 36979787

  • Chaker L, Razvi S, Bensenor IM, Azizi F, Pearce EN, Peeters RP. Publisher Correction: Hypothyroidism. Nat Rev Dis Primers. 2022 Jun 10;8(1):39. doi: 10.1038/s41572-022-00373-7. No abstract available.

    PubMed 35688906

  • Nassar M, Hassan A, Ramadan S, Desouki MT, Hassan MA, Chaudhuri A. Evaluating the effectiveness of combined T4 and T3 therapy or desiccated thyroid versus T4 monotherapy in hypothyroidism: a systematic review and meta-analysis. BMC Endocr Disord. 2024 Jun 14;24(1):90. doi: 10.1186/s12902-024-01612-6.

    PubMed 38877429

  • Ali ZH, Abdulridha MK, Alzajaji QB. Screening factors affecting proper levothyroxine therapy among patients with primary hypothyroidism: a cross-sectional study. J Med Life. 2024 Feb;17(2):177-187. doi: 10.25122/jml-2023-0387.

    PubMed 38813351

  • Hage MP, Azar ST. The Link between Thyroid Function and Depression. J Thyroid Res. 2012;2012:590648. doi: 10.1155/2012/590648. Epub 2011 Dec 14.

    PubMed 22220285

Questions about this trial

What is this clinical trial studying?

An observational study of Hypothyroidism Primary, run by Assiut University at 1 site in Egypt.

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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of chronic fatigue in patients with hypothyroidism at Assuit University Hospitals. (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT06660888, which also lists 8 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 4 Feb 2025.

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