RE104 Safety and Efficacy Study in Postpartum Depression
RECRUITMENT FOR STUDY
Study Sponsored by Reunion Neuroscience
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo.
This study will compare a single dose treatment of 2 different strengths of RE104, a low dose (1.5 mg) and a high dose (30 mg). Study participants will be randomly assigned (like the flip of a coin) to receive one of the doses and neither they nor the Study Doctor will know which dose is given.
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 2 weeks, this may be a sign of PPD. Postpartum depression is a serious mental health condition that affects behavior and physical health.
- Depressed mood is present most of the day
- Loss of interest or pleasure, most of the day
- Insomnia or sleeping too much
- Unusually slow or fast movements
- Feelings of worthlessness or guilt
- Loss of energy or fatigue
- Suicidal thoughts
- Impaired concentration or indecisiveness
- Change in weight or appetite
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 US FDA for treatment of any condition. The FDA and ethics review board have, however, reviewed this study.
Screening and Baseline Period
Women who may qualify for and are interested in participating in this study will be asked to visit with study staff for a Screening Visit up to 3 weeks before the Treatment Period. Before a potential participant decides to proceed with this study, the study staff will review with her a document called the informed consent form. This document will provide a detailed explanation of the study and its potential risks and benefits. After the potential participant reads the form, the study staff will answer any questions she may have. Then, if the participant wishes to proceed, she will sign the informed consent form to confirm that she understands what it means and is willing to participate in the study. Study participation is completely voluntary at all times.
During the Screening Visit, participants will discuss their symptoms with study staff and complete several assessments and tests to confirm eligibility to be in the study. Participants will also be asked to identify a caretaker who can look after their baby for a full day while they are undergoing study treatment (called a dosing session) and for 24 hours after dosing.
During screening, the specially trained and qualified site staff members, called Session Monitors, will prepare and teach the participant about the treatment and dosing experiences and management for the effects of RE104 during the dosing session.
Study Treatment/Dosing Session
After all tests are completed and when the Study Doctor determines a participant is ready for dosing, 1 injection of RE104 will be given in the upper arm. The visit will last at least 8 hours after receiving RE104 or until the effects of RE104 have worn off.
The dosing will take place in a comfortable room, where participants can lie on a bed or couch, listen to music, and relax. At least one of the Session Monitors familiar to the participant will always be in the session room to provide support.
Follow Up
Participants will take part in 7 Follow-up visits which will begin the day after receiving RE104 to monitor health and the effect of the study drug. 4 of these visits will be at the study center and up to 3 may be remote visits by telephone. Two of the Follow-up visits will include Integration Sessions. During these, participants and their Session Monitor will discuss the experience with RE104 during the Dosing Session and address any safety concerns, if present.
To inquire about participation in the RE104: Reconnect Study, apply below: