Clinical Trial 46262

Pinellas Park, FL 33782


Summary:

A study to evaluate the efficacy andsafety of SAGE-217, an oral medication, in patients with severe post-partum depression.  Study medication is taken for 15 days and follow-up continues for 30 additional days.  A screening period is used to assess eligibility.  Participants will be seen at the clinic 9 times throughout the study and will be assessed by a psychiatrist to confirm the diagnosis.  All subjects will be tested for drugs and alcohol.  Labs are required at most visits.  



Inclusion Criteria:

  • Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
  • Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
  • Participant is ≤12 months postpartum at screening and Day 1.


Qualified Participants May Receive:

All study medication, examinations, and labs will be included.  Stipends are allowed for formula and a breat pump during the study.  Transportation is provided.  Sitpends are paid for each completed visit.  There is no out-of-pocket expense to participants.


Available At:

DMI Research
6699 90th Ave. N.
Pinellas Park, FL 33782
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If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.