Investigating stress and inflammation in women with major depressive disorder and premenstrual dysphoric disorder
Official title: Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder
Run by University Hospital Tuebingen · NCT06130371 · Data updated 2026-11-12
This study is testing how stress and inflammation affect women with major depressive disorder and premenstrual dysphoric disorder during different times in their menstrual cycle to help find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 75 (estimated) |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen, Baden-Wurttemberg) |
| Status | Recruiting |
| Started | January 4, 2024 |
| Main results expected | June 2026 |
| Study ends | July 2026 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT06130371 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 to 40 with regular menstrual cycles who are fluent in German.
✕Probably not a fit
Patients with neurological or mental diseases, hormonal treatments, or those who are pregnant or breastfeeding 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 aims to compare the neural correlates and stress responses of women with major depressive disorder (MDD), women with premenstrual dysphoric disorder (PMDD), and healthy control women. Participants will be assessed during two different phases of their menstrual cycle to understand how hormonal changes affect stress reactivity. The study will measure behavioral, neural, immunological, and endocrine profiles to elucidate the psychobiological characteristics of these conditions. The findings could help in developing more targeted treatments for these disorders.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for women suffering from MDD and PMDD.
How similar studies have gone: While there is ongoing research into MDD and PMDD, this specific comparative approach focusing on stress and inflammation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women, * age between 18 and 40 years (no menopausal women), * regular menstrual cycles (25-31 days), * normal body mass index (18-35 kg/m2), * German language fluency Exclusion Criteria: * any neurological or mental disease (only for healthy participants) * hormonal, metabolic or chronical diseases * pregnancy * women who gave birth or were breastfeeding within the last year * women with any kind of steroid hormonal treatment * oral contraceptive treatment in the last three months * psychotropic treatment, only if regular * engagement in competitive sports * shift work
Where it's running
-
University Hospital Tübingen, Klinik für Psychiatrie und Psychotherapie
Tübingen, Baden-Wurttemberg, Germany Recruiting
Study contacts
- Principal investigator: Andreas Fallgatter, Prof. Dr. — Universitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie
- Study coordinator: Elise Bücklein, M.Sc.
- Email: elise.buecklein@uni-tuebingen.de
- Phone: +497071-2982627
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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.