IRB Study Number 24-777
Status Recruiting
Phase Phase 2
Location Lutheran Hospital
Institute Neurological Institute
Description
Reunion is developing the experimental drug RE104 as a potential new treatment for some psychiatric conditions such as postpartum depression (PPD). RE104 belongs to a class of drugs called psychedelics. RE104 is a psychedelic substance similar to psilocybin (also known as magic mushrooms). RE104 is an investigational drug. This means that RE104 is still being studied and it has not been approved by the United States Food and Drug Administration (FDA) for any purpose. RE104 is designed to act on the serotonin system in the brain which is linked to mood and mental health. The reason for this study is to further investigate the safety of the study drug, called RE104, and see if it can reduce depressive symptoms in people with PPD.
This study will compare 2 different doses of RE104, a low dose (1.5 mg) and a high dose (30 mg). The 30 mg dose is less than the highest dose that has already been given to healthy adult participants in another research study. The study drug, RE104, will be given as a one time under the skin shot (or injection) in your upper arm at the study clinic. A member of the study staff will administer the study drug. If you decide to participate, you will be randomly assigned (like a coin toss) to receive either the low or high dose of RE104. You and your Study Doctor (including the study staff) will not know which dose of RE104 you are getting (either 1.5 mg or 30 mg). If there is a medical emergency, the Study Doctor can find out what dose you received.
This study will compare 2 different doses of RE104, a low dose (1.5 mg) and a high dose (30 mg). The 30 mg dose is less than the highest dose that has already been given to healthy adult participants in another research study. The study drug, RE104, will be given as a one time under the skin shot (or injection) in your upper arm at the study clinic. A member of the study staff will administer the study drug. If you decide to participate, you will be randomly assigned (like a coin toss) to receive either the low or high dose of RE104. You and your Study Doctor (including the study staff) will not know which dose of RE104 you are getting (either 1.5 mg or 30 mg). If there is a medical emergency, the Study Doctor can find out what dose you received.
Inclusion Criteria
Key Inclusion Criteria:
-Is ≤12 months postpartum at Screening.
-Meets 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.
Exclusion Criteria
Key Exclusion Criteria:
-History or active postpartum psychosis per Investigator assessment.
-History of treatment-resistant depression within the current postpartum depressive episode.
-Has a significant risk of suicide.
-Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder.
-Medically significant condition rendering unsuitability for the study .
-Has received electroconvulsive therapy (ECT) or transcranial magnetic stimulation within 90 days prior to Screening.-Has used psychedelics such as psilocybin, ayahuasca, mescaline, or LSD (with the exception of cannabis) within 12 months prior to Screening.
-Has used or will need to use prohibited medications.
