RE104 Safety and Efficacy Study in Postpartum Depression
This Phase II, randomised, triple-blind, active-dose-controlled trial (n=84) evaluated a single subcutaneous dose of RE104 in adults with moderate-to-severe postpartum depression. Participants received either 30 mg RE104 or a 1.5 mg active-control dose in a parallel-group design. The primary outcome compared change from baseline in Montgomery-Åsberg Depression Rating Scale total score between the two dose groups at Day 7. Secondary assessments examined depressive response and remission, clinical global improvement, anxiety symptoms and treatment-emergent adverse events through 28 days after dosing.
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Detailed Description
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-control.
Study Arms & Interventions
RE104 1.5 mg
active comparatorA single subcutaneous injection of 1.5 mg RE104 for Injection
Interventions
- Psilocybin1.5 mgvia Subcutaneous• single dose• 1 doses total
Luvesilocin (RE104); represented under Blossom’s Psilocybin compound record.
RE104 30 mg
experimentalA single subcutaneous injection of 30 mg RE104 for Injection
Interventions
- Psilocybin30 mgvia Subcutaneous• single dose• 1 doses total
Luvesilocin (RE104); represented under Blossom’s Psilocybin compound record.
Participants
Inclusion Criteria
- Is ≤15 months postpartum at Screening.
- Meet 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
- 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.
Study Protocol, Arms & Participants
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Study Details
- StatusCompleted
- PhasePhase II
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment84 participants
- TimelineStart: 2024-06-14End: 2025-06-16
- Compound
- Topic
Study Team
Sponsors & Collaborators
- Reunion NeurosciencePrimary Sponsor
Locations
Recent activity
- CompletedRE104 Safety and Efficacy Study in Postpartum Depression (NCT06342310, psilocybin)
- StartedRE104 Safety and Efficacy Study in Postpartum Depression (NCT06342310, psilocybin)
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