Status:

RECRUITING

A Study of a Test for Postpartum Depression at Home

Lead Sponsor:

University of Virginia

Collaborating Sponsors:

Mayo Clinic

Dionysus Health

Conditions:

Postpartum Depression (PPD)

Pregnancy

Eligibility:

FEMALE

18+ years

Brief Summary

The study will seek to prospectively validate the Enlighten Device for prediction of PPD by examining true/false positive and negative rates of the test using PPD outcomes collected through 3 months p...

Eligibility Criteria

Inclusion

  • subject must be pregnant (singleton pregnancy)
  • \<30 weeks' gestation, age 18 or above
  • able to provide written consent in English

Exclusion

  • The study team and/or PI may exclude anyone deemed unsafe to participate in the protocol.

Key Trial Info

Start Date :

November 20 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2030

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT07186309

Start Date

November 20 2025

End Date

August 1 2030

Last Update

November 28 2025

Active Locations (1)

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1

University of Virginia

Charlottesville, Virginia, United States, 22903