Postpartum depression is a serious is and life-changing condition many women go through after having a baby. if you or a loved one suffers from severe postpartum depression (PPD), you or they may be eligible to take part in a clinical research study to evaluate the safety and efficacy of an investigational medication. This study medication is an oral, immediate-release tablet, taken for only 3 days for a total of 5 doses. Participants taking part in the study will be monitored closely through an inpatient stay while receiving the study medicine, and through follow-up visits thereafter.
will be recruited into this study across the United States. Participants who enroll in this study will be asked to participate for up to 60 days, composed of 1 screening visit, 3 night in-patient stay, and 2 follow-up visits. During this 60-day time frame, participants will be asked to stay at the study site for 4 consecutive day for study treatment and return twice more for follow-up visits in the weeks after.
into the study will be assigned by random choice to receive either investigational medicine or placebo during the study. The placebo looks like the active investigational medicine, though does not contain any active medicine, and cannot provide any treatment benefit. During the study, investigational medicine or placebo will be provided by healthcare professionals at the study site. Women must refrain from breastfeeding their child for 14 days during this study.
in this study, participants
* Must be female ages 18 - 45
* Must have been diagnosed with postpartum depression, with a depressive episode beginning between the 3rd trimester and 4th week postpartum
* Must have had a baby within the last 9 months.
Participants receive investigational drug at no cost. Reimbursement for study-related time, travel, and childcare may be available.
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