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NCT05678374
Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease
trial in Graves Disease in 180 participants. Currently enrolling.
20 December 2028
Quick facts
| Lead sponsor | Vastra Gotaland Region |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 180 |
| Start date | 1 October 2019 |
| Primary completion | 20 December 2028 |
| Estimated completion | 20 December 2028 |
| Sites | 1 location across Sweden |
Conditions studied
- Graves Disease — all drugs for Graves Disease →
- Graves Ophthalmopathy — all drugs for Graves Ophthalmopathy →
- Mental Fatigue — all drugs for Mental Fatigue →
- Autoimmune Diseases — all drugs for Autoimmune Diseases →
Sponsor
Vastra Gotaland Region — full company profile →
Who can join
Adults 18 to 72, female only, with Graves Disease or Graves Ophthalmopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored hyperthyroidism in Graves' disease is an autoimmune complication. The aim of this study is to explore immunological markers possibly associated with mental fatigue in Graves' disease, which the investigators plan to validate in another study (ImmunoGraves wp 2). Using a cross-sectional study design, mental fatigue is scored using a questionnaire to find 60 patients with and 60 without mental fatigue 15-60 months after diagnosis of Graves disease. The patients and 60 thyroid healthy controls without mental fatigue are assessed for thyroid hormones, quality of life, anxiety and depression, self-evaluated stress, coping strategies, eye symptoms and background variables. SciLifeLab in Stockholm, the national facility for autoimmune profiling, has pre-set large arrays including 42000 human proteins. Serum and cerebrospinal fluid will be separately pooled and analysed for a subgroup of patients with or without mental fatigue and for a subgroup of the control group. Proteins that preferably bind to antibodies in sera and/or cerebrospinal fluid from Graves' patients with mental fatigue in comparison to non-mental fatigue patients, will be screened against the Human Protein Atlas and the Allen brain map to identify those proteins that are expressed in the brain. Antibodies at higher concentration in the mental fatigue pools compared to the group without mental fatigue will be selected for further analyses on an individual level in the whole cohort together with antibodies targeting g-protein coupled receptors, thyroid autoantibodies, cytokines and biomarkers indicating organic and structural nerve damage.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Brain fatigue in Graves' disease: symptoms and presentation of a possible mechanism at the cellular level.
Tammelin K, Holmberg M, Lindo A, Johansson B, et al · · 2026 · PMID 41711390 · DOI 10.1530/etj-25-0172
Verify or expand the search:
- PubMed search for NCT05678374
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Graves Disease
Currently open trials in the same condition.
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- NCT07286656 — A Study of GensSci098 in Subjects With Graves' Disease · Phase 1 · recruiting
- NCT07129642 — Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease · EARLY_PHASE1 · recruiting
- NCT07369063 — Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease · Phase 2 · recruiting
Other Vastra Gotaland Region trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05678374 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vastra Gotaland Region
- Last refreshed: 29 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05678374.
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