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 type | Observational |
|---|---|
| Ages | 18 Years to 72 Years |
| Sex | All |
| Enrollment | 430 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Status | Recruiting |
| Started | September 12, 2019 |
| Main results expected | December 20, 2029 |
| Study ends | December 20, 2030 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT06081439 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.
-
Efgartigimod for Graves' Disease in adults
We are testing if efgartigimod given under the skin can help adults with Graves' disease by improving thyroid function and whether it is safe and tolerable.
-
ETHY-001 safety and activity in Thyroid Eye Disease (TED)
This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.
-
Acute Mental Fatigue and Lower-Body Muscle Strength in Young Adults
This study tests whether a computer-based mental fatigue task changes knee and leg muscle strength and limb symmetry in healthy young adults.
-
Early risk stratification of thyroid eye disease in newly diagnosed Graves' disease
This study tests whether early eye-related signs, blood and tear biomarkers, or eye surface features can predict who with Graves’ disease will develop thyroid eye disease within a year.
-
Felzartamab for Graves’ Disease: See if it helps control thyroids and reduce need for ATDs
This study tests felzartamab vs placebo in adults with Graves’ disease to see if it can normalize thyroid hormones and let people stop anti-thyroid drugs.
-
AI-based MRI and ultrasound for thyroid-related eye disease
This study tests an AI model using orbital MRI and eye ultrasound to help diagnose activity and severity of thyroid-associated ophthalmopathy and predict its course in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.