A Study Evaluating the Safety and Effectiveness of RE104, a Psilocybin-like substance, in the Treatment of Patients with Postpartum Depression

Primary Objective

This study is testing if a single dose of the psychedelic drug RE104 can help reduce symptoms of moderate-to-severe postpartum depression compared to a placebo in pregnant women aged 18 to 45.

Is This Study For You?

Let's Get Started!

Description

After having a baby, some women feel sad, worried, or tired. This is known as the "baby blues" and for many women this usually goes away in a few days. However, if these feelings last for more than two weeks, this may be a sign of postpartum depression (PPD). PPD is a serious condition that affects your behavior and physical health. If you have PPD, you might feel sad and hopeless, and these feelings may interfere with your daily life. Researchers are looking for treatments to help with PPD. This study is evaluating RE104, an investigational drug, as a potential new treatment for PPD as compared to placebo. A placebo looks the same as and is given the same way as the drug being studied but has no active ingredients. 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.

Main Procedures Involved: If you choose to volunteer for the study, you will be randomly assigned to either the study drug (RE104) or the placebo. This means you won’t get to choose which one you get, like flipping a coin. You will fill out several questionnaires to check your depression and anxiety, and the severity of your symptoms.

Duration of Participation: You will complete ten study visits, each lasting about 30 to 60 minutes with the exception of the Treatment Day. This visit will be between 8-10 hours long. Some visits may be done remotely. The in-person visits will be before you start treatment, on your treatment day, one day after treatment, one week after treatment, two weeks, and one month after treatment. Your participation in the study will be about 30 days.

Details
Age
18-45 years of age
Eligibility
  • 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
Additional inclusion and exclusion criteria will be checked by a health care professional or study staff at your first visit.
Compensation
Earn up to $700 if you complete all visits
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

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers