RE104 Safety and Efficacy Study in Postpartum Depression

Phase 2

Active, not recruiting

• Conditions: Postpartum Depression
• Interventions: Drug: RE104 for Injection

• Registration Number: NCT06342310
• Lead Sponsor: Reunion Neuroscience Inc

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-placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-02
• Study Start: 2024-06-14
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 mg RE104	RE104 for Injection	A single subcutaneous injection of 30 mg RE104 for Injection
1.5 mg RE104	RE104 for Injection	A single subcutaneous injection of 1.5 mg RE104 for Injection

Primary Outcome Measures

Name	Time	Method
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score	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 Outcome Measures

Name	Time	Method
RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline)	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.
RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)	Day 1, Day 7 and Day 28	The Clinical Global Impression - Severity Scale is a clinician-rated instrument that grades severity of symptoms on a scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients).
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score	Day 1, Day 14 and Day 28	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.
RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10)	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.
RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)	Day 7	The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I)	Day 1, Day 7 and Day 28	The Clinical Global Impression - Improvement (CGI-I) Scale is a clinician-rated instrument that weighs the clinical impact of the identified symptom(s) on behavior and function and measures changes in psychopathology since the treatment was administered on a scale from 1 (very much improved) to 7 (very much worse).
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)	A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.

Trial Locations

Locations (1)

Reunion Investigational Site; 🇺🇸 Madison, Wisconsin, United States