Exploring the links between inflammation, cognitive function, and brain changes in people with depression
The Relations Among Endotoxin, Inflammatory Cytokines, Cognitive Markers and Brain MRI Changes in Subjects With Depressive Disorder
Lithuanian University of Health Sciences · NCT06203015
This study is trying to see how inflammation and brain changes affect thinking skills in people with depression to help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lithuanian University of Health Sciences (other) |
| Locations | 2 sites (Kaunas and 1 other locations) |
| Trial ID | NCT06203015 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationships among endotoxin levels, inflammatory cytokines, cognitive markers, and brain MRI changes in individuals diagnosed with Major Depressive Disorder (MDD). It aims to understand the complex interplay of these factors, which may contribute to the low remission rates observed in MDD patients. Participants will undergo cognitive testing, blood sample collection, and brain imaging to gather data on their condition. The study seeks to identify potential biomarkers that could help stratify MDD subtypes and improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with Major Depressive Disorder.
Not a fit: Patients with other mental disorders or significant somatic diseases that could affect inflammatory factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better-targeted treatments for patients with Major Depressive Disorder by identifying specific biomarkers.
How similar studies have performed: While the study explores established concepts in depression research, the specific approach of linking endotoxin and cognitive markers in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years old * signed informed consent * patients diagnosed with MDD (according to the WHO's \[2019\] International Classification of Diseases and related health problems categorization of mental disorders) for MDD group. Exclusion Criteria: * diagnosis of other mental disorders during the past one-year period (for MDD group). * diagnosis of any mental disorders within the past one-year period, previous suicide attempt, or current suicide risk identified in the study (for control group). * diagnosis of somatic diseases that may affect changes in inflammatory factors in the body (for both groups)
Where this trial is running
Kaunas and 1 other locations
- Psychiatry Department, Hospital of Lithuanian University of Health Sciences Kaunas Clinics — Kaunas, Lithuania (RECRUITING)
- Psychiatry Department, Hospital of Lithuanian University of Health Sciences Kaunas Clinics — Kaunas, Lithuania (RECRUITING)
Study contacts
- Principal investigator: Vesta Steibliene, PhD, MD — Proffesor, Lithuanian University of Health Sciences
- Study coordinator: Egle Milasauskiene, MD
- Email: egle.milasauskiene@lsmu.lt
- Phone: +37063458861
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Inflammation, Cognitive Dysfunction, Endotoxemia, Genetic Predisposition to Disease, Blood Brain Barrier Defect, Major depressive disorder, Endotoxin