Last reviewed · How we verify
NCT06771583: BIO
Identification and Validation of Epigenetic Biomarkers of PMDD
trial in PMDD in 500 participants. Currently enrolling.
15 February 2030
Quick facts
| Lead sponsor | Johns Hopkins University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 12 September 2025 |
| Primary completion | 15 February 2030 |
| Estimated completion | 15 February 2031 |
| Sites | 1 location across United States |
Conditions studied
- PMDD — all drugs for PMDD →
- Premenstrual Dysphoric Disorder (PMDD) — all drugs for Premenstrual Dysphoric Disorder (PMDD) →
- Premenstrual Syndrome-PMS — all drugs for Premenstrual Syndrome-PMS →
- Premenstrual Syndrome — all drugs for Premenstrual Syndrome →
Sponsor
Johns Hopkins University
Who can join
Adults 18 to 50, female only, with PMDD or Premenstrual Dysphoric Disorder (PMDD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This research is being done to examine epigenetic markers and mood changes across the menstrual cycle, particularly in premenstrual dysphoric disorder (PMDD). The investigators previously identified epigenetic biomarkers of postpartum depression, another reproductive affective disorder, and in this study aim to determine if these biomarkers also distinguish PMDD cases from healthy controls at different points in the menstrual cycle. By collecting biological samples (such as blood) and monitoring mood changes across the menstrual cycle, the investigators will be able to determine whether these epigenetic markers are associated with PMDD. The investigators plan to study these epigenetic markers during the follicular phase (roughly the first half of the menstrual cycle, from menses until ovulation) and the luteal phase (roughly the second half of the menstrual cycle, from ovulation to menses). The investigators will study this in two groups: 1) individuals who do NOT have premenstrual mood symptoms, and 2) individuals with premenstrual syndrome/premenstrual dysphoric disorder (PMS/PMDD). The results will provide a comprehensive view of the changes in these systems across the menstrual cycle. This will add to the investigators understanding of the mechanisms that may cause PMS/PMDD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06771583
- Europe PMC full search
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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 NCT06771583 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
- Last refreshed: 22 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/NCT06771583.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing