A team of researchers at Cleveland Clinic plans to conduct a clinical trial to test a proprietary psychedelic aimed at treating postpartum depression. This serious condition affects approximately 1 in 7 women after giving birth.
The Phase 2 trial centers on RE104, a formulation that is similar to psilocybin. It is designed to be administered subcutaneously via an injection and the patient requires just one dose of this treatment. It is hoped that this treatment will address the clinical needs of new mothers afflicted by PPD and experience symptoms like sleep disturbances, chronically low mood, feelings of guilt or inadequacy, and detachment from the infant. Some new mothers suffering from this condition even consider committing infanticide or self-harm.
Dr. Brian Barnett, who will lead the team of investigators, hopes that the trial will provide a safe solution for those patients diagnosed with PPD. Dr. Barnett explains that historically, the treatment options available for women with PPD have been very limited and none are specifically approved to treat postpartum depression. Furthermore, those treatment options often come with disadvantages like posing a risk to breast milk supply and production in addition to those treatments taking long to start taking effect. Some of those drugs also require long administration times, which keep mothers away from their homes and babies for days in a row.
This is where the psychedelic option comes in, Dr. Barnett says. Psychedelics have been shown to take effect fast and they come with relatively few side effects. He says they hope the trial will deliver the needed relief within a short time so that mothers can quickly get back to their babies. They also hope that the treatment will be found to pose no risk to the newly born babies. Previous tests have shown that the majority of women who receive this treatment can resume breastfeeding 24 hours or less after the drug has been administered.
For this Phase 2 study, the study participants will undergo extensive psychological and physical testing and be enabled to know the team of researchers. On the drug administration day, each patient will have a person assigned to monitor them and this monitor is expected to be with the patient the entire treatment time lasting 2 hours. After the drug is administered, patients will be monitored for 6 hours and then undergo psychiatric evaluation before being allowed to return home. The following four weeks will have a number of follow-up visits intended to ascertain how symptom severity is altering.
It is hoped that the study findings will take this drug a step closer to giving patients needed relief, especially those who aren’t responding to the existing treatment options. Companies like Compass Pathways PLC (NASDAQ: CMPS) that are also conducting psychedelic drug development programs will be hoping that the different ongoing trials result in approved treatments that bring psychedelic medicine into the mainstream.
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