A Study Evaluating the Safety and Effectiveness of RE104, a Psilocybin-like substance, in the Treatment of Patients with Postpartum Depression (PPD)
Primary Objective
This study wants to see if giving patients with moderate-to-severe postpartum depression a single dose of a psychedelic drug called RE104 reduces depressive symptoms as compared to patients that receive a placebo drug. A placebo is inactive version of the drug that looks the same as, and is given the same way as, an active drug.
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
- 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 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
Camille Hoffman-Shuler
Study ID
Protocol Number: 24-0776
Categories
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