RE104 Safety and Efficacy Study in Postpartum Depression

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)

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 Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: Drug: RE104 for Injection

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Reunion Investigational Site
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Reunion Investigational Site
  • California
    • Santa Monica, California, United States, 90404
      • Reunion Investigational Site
  • Colorado
    • Boulder, Colorado, United States, 80045
      • Reunion Investigational Site
    • Denver, Colorado, United States, 80209
      • Reunion Investigational Site
  • Florida
    • Lauderhill, Florida, United States, 33319
      • Reunion Investigational Site
    • Tampa, Florida, United States, 33613
      • Reunion Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Reunion Investigational Site
    • Atlanta, Georgia, United States, 30331
      • Reunion Investigational Site
    • Decatur, Georgia, United States, 30030
      • Reunion Investigational Site
    • Marietta, Georgia, United States, 30060
      • Reunion Investigational Site
    • Savannah, Georgia, United States, 31405
      • Reunion Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Reunion Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Reunion Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Reunion Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Reunion Investigational Site
    • Rockville, Maryland, United States, 20850
      • Reunion Investigational Site
  • Massachusetts
    • Springfield, Massachusetts, United States, 01103
      • Reunion Investigational Site
  • Michigan
    • Novi, Michigan, United States, 48377
      • Reunion Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Reunion Investigational Site
  • New York
    • Buffalo, New York, United States, 14202
      • Reunion Investigational Site
    • New York, New York, United States, 10016
      • Reunion Investigational Site
    • New York, New York, United States, 10026
      • Reunion Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Reunion Investigational Site
    • Monroe, North Carolina, United States, 28112
      • Reunion Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44113
      • Reunion Investigational Site
    • Columbus, Ohio, United States, 43210
      • Reunion Investigational Site
  • Pennsylvania
    • West Chester, Pennsylvania, United States, 19380
      • Reunion Investigational Site
  • Texas
    • Austin, Texas, United States, 78712
      • Reunion Investigational Site
    • Austin, Texas, United States, 78737
      • Reunion Investigational Site
    • Austin, Texas, United States, 78759
      • Reunion Investigational Site
    • Plano, Texas, United States, 75093
      • Reunion Investigational Site
    • San Antonio, Texas, United States, 78229
      • Reunion Investigational Site
  • Utah
    • Draper, Utah, United States, 84020
      • Reunion Investigational Site
    • Salt Lake City, Utah, United States, 84108
      • Reunion Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Reunion Investigational Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Reunion Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Reunion Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1.5 mg RE104; A single subcutaneous injection of 1.5 mg RE104 for Injection	Drug: RE104 for Injection; Single, subcutaneous dose of RE104 for Injection
Experimental: 30 mg RE104; A single subcutaneous injection of 30 mg RE104 for Injection	Drug: RE104 for Injection; Single, subcutaneous dose of RE104 for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score	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.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I)	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).	Day 1, Day 7 and Day 28
RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)	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).	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.	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.	From dosing through study completion (post-dose follow-up is for 28 days)
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score	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.	Day 1, Day 14 and Day 28
RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline)	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.	Day 7
RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10)	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.	Day 7
RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)	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.	Day 7

Collaborators and Investigators

• Sponsor: Reunion Neuroscience Inc
• Investigators: Study Director: Jasna Hocevar-Trnka, M.D., Reunion Neuroscience Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Actual): May 22, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: RE104-201-PPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No