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A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients with Postpartum Depression (PPD)

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Description

After having a baby, some women get the "baby blues" or feel sad, worried or tired within a few days of giving birth. For many women, the baby blues go away in a few days. However, if any of the following symptoms persist for more than two weeks, this may be a sign of postpartum depression (PPD). Postpartum depression is a serious mental health condition that affects behavior and physical health. If you have PPD, the sad and hopeless feelings do not go away and may interfere wtih your day-to-day life. Medical researchers continue to look for treatments that can help. This research study is evaluating RE104, an investigational drug, as a potential new treatment for mental health conditions including PPD. RE104 belongs to a class of drugs called psychedelics. RE104 is "investigational" because it is still being studied and is not yet approved by the FDA for treatment of any condition.

Details
Age
Adult
Eligibility
18-45 years of age, is less than 12 months postpartum, experiencing a major depressive episode that began at any time starting in the 2nd trimester of pregnancy or through four weeks post-delivery. Is <12 months postpartum at Screening. Meet DSM-5 criteria for postpartum depression (PPD): experiencing a major depressive episode that began at any time starting at the beginning of the second trimester (≥14 weeks) of pregnancy through 4 weeks post-delivery. Has a Hamilton Depression Scale (HAM-D) total score meeting severity threshold at Screening and Baseline. Is not using any psychotropic medications or psychotherapy for 30 days prior to Screening, OR are on an already stable/established regimen of SSRIs or psychotherapy for 30 days prior to Screening. Has ceased breastfeeding at Screening. Has a negative pregnancy test at Screening and Day 0 prior to study drug administration
Locations

Department Specific Free Standing Clinic
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Camille Hoffman-Shuler

Camille Hoffman-Shuler

Study ID

Protocol Number: 24-0776

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