Clinical trial Recruiting at 1 site Observational Ages 18 to 72

Exploring immune markers linked to mental fatigue in Graves' disease

Official title: Validating Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Graves' Disease and Their Association With Functional Changes in Neuronal Activation

Run by Vastra Gotaland Region · NCT06081439 · Data updated 2026-11-12

This study looks at whether certain immune markers are linked to ongoing mental fatigue in people with Graves' disease after their thyroid levels are back to normal.

Quick facts

Study typeObservational
Ages18 Years to 72 Years
SexAll
Enrollment430 (estimated)
SponsorVastra Gotaland Region
Government
Locations1 site (Gothenburg)
StatusRecruiting
StartedSeptember 12, 2019
Main results expectedDecember 20, 2029
Study endsDecember 20, 2030
Registry record updatedSeptember 10, 2026
Trial IDNCT06081439 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals recently diagnosed with Graves' disease who have elevated thyroid hormones and positive TSH-receptor antibodies.

Probably not a fit

Patients with pre-existing neurological diseases, psychosis, or those unable to complete questionnaires in Swedish may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the relationship between immunological markers and mental fatigue in patients diagnosed with Graves' disease. It aims to confirm the association of these markers with persistent mental fatigue after achieving normal thyroid function. A total of 310 patients will be assessed for various psychological and physical symptoms at different stages of their treatment, including before and after achieving euthyroidism. Blood and cerebrospinal fluid samples will be collected to analyze the identified biomarkers alongside thyroid hormones and autoantibodies.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of mental fatigue in patients with Graves' disease.

How similar studies have gone: While the specific approach of this study is novel, similar studies exploring the link between autoimmune conditions and mental health have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Recently diagnosed Graves' disease
* Positive thyroid stimulating hormone (TSH)-receptor antibodies (TRAb)
* Thyroid hormones above the upper reference limit
* Inclusion within three weeks after start of antithyroid drugs

Controls: Matched for gender and age

Exclusion Criteria:

* Person unable to follow protocol as with psychosis, dementia or not able to answer questionnaires in Swedish.
* Recidive of Graves' disease
* Pregnancy

Controls: -Thyroid disease

* Neurological disease

Where it's running

  • Endokrina Forskningsenheten, Sahlgrenska University Hospital
    Gothenburg, Sweden
    Recruiting

Study contacts

  • Principal investigator: Helena Filipsson, ass prof — Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Department of Endocrinology, Sahlgrenska University Hospital, Wallenberg Center for Molecular and Translational Medicine, all in Gothenburg, Sweden
  • Study coordinator: Karin Tammelin, PhD student
  • Email: karin.tammelin@vgregion.se
  • Phone: +46313427331

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.