NCT06342310CompletedPhase 2
A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients With Postpartum Depression (PPD)
Reunion Neuroscience Inc39 sites in 1 country84 target enrollmentStarted: June 14, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Reunion Neuroscience Inc
- Enrollment
- 84
- Locations
- 39
- Primary Endpoint
- RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1.5 mg RE104
Active Comparator
A single subcutaneous injection of 1.5 mg RE104 for Injection
Intervention: RE104 for Injection (Drug)
30 mg RE104
Experimental
A single subcutaneous injection of 30 mg RE104 for Injection
Intervention: RE104 for Injection (Drug)
Outcomes
Primary Outcomes
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Time Frame: Day 7
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
Secondary Outcomes
- RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline)(Day 7)
- RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)(Day 1, Day 7 and Day 28)
- RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score(Day 1, Day 14 and Day 28)
- RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10)(Day 7)
- RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)(Day 7)
- RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I)(Day 1, Day 7 and Day 28)
- RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.(From dosing through study completion (post-dose follow-up is for 28 days))
Investigators
Study Sites (39)
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Related News
Reunion Neuroscience Completes Patient Dosing in Phase 2 Trial of Novel Psychedelic for Postpartum Depression- Reunion Neuroscience has completed patient dosing in its RECONNECT Phase 2 trial evaluating RE104, a short-duration psychedelic therapy for postpartum depression, with topline results expected in Q3 2025.
- The multicenter trial enrolled 84 adult female patients with moderate-to-severe PPD across 38 U.S. clinical sites, assessing the safety and efficacy of a single subcutaneous dose of RE104.
- RE104 is designed to deliver a shorter psychedelic experience (3-4 hours) compared to psilocybin or LSD, while maintaining similar intensity and a favorable safety profile based on Phase 1 results.last yearReunion Neuroscience to Launch REKINDLE Phase 2 Trial for Adjustment Disorder in Cancer Patients Using Psychedelic Therapy• Reunion Neuroscience has unveiled plans for REKINDLE, a Phase 2 clinical trial evaluating RE104, a novel psychedelic therapeutic, for adjustment disorder (AjD) in patients with cancer and other serious medical illnesses.
• AjD affects approximately 500,000 Americans annually following medical diagnoses, with no FDA-approved treatments currently available despite its significant impact on treatment outcomes and quality of life.
• RE104, a proprietary prodrug of 4-OH-DiPT, offers a shorter psychedelic experience (3-4 hours) compared to psilocybin while maintaining similar therapeutic potential, with trial initiation expected mid-2025.last yearReunion Neuroscience Initiates Phase 2 Trial of Fast-Acting Psychedelic RE104 for Postpartum Depression• Reunion Neuroscience has dosed the first patient in its RECONNECT Phase 2 trial evaluating RE104, a novel psychedelic prodrug designed for single-dose treatment of postpartum depression.
• RE104 offers a shorter psychedelic experience (3-4 hours) compared to psilocybin while maintaining similar intensity and safety profile, potentially addressing the need for fast-acting PPD treatments.
• The randomized, double-blind trial will assess efficacy through changes in depression severity scores, with primary endpoints measured at day 7 and follow-up assessments through day 28.2 years ago