RE104 Safety and Efficacy Study in Postpartum Depression

NCT06342310 | Completed Phase 2 FDA Drug

• 1 other identifier: RE104-201-PPD
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 38

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 response (≥ 50 percent reduction in score from baseline)

  Day 7

• 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 Clinical Global Impression-Improvement (CGI-I)

  Day 1, Day 7 and Day 28

• RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)

  Day 1, Day 7 and Day 28

Study Arms (2)

1.5 mg RE104

ACTIVE COMPARATOR

A single subcutaneous injection of 1.5 mg RE104 for Injection

Drug: RE104 for Injection

30 mg RE104

EXPERIMENTAL

A single subcutaneous injection of 30 mg RE104 for Injection

Drug: RE104 for Injection

Interventions

RE104 for Injection DRUG

Single, subcutaneous dose of RE104 for Injection

1.5 mg RE104; 30 mg RE104

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reunion Neuroscience Inc: lead

Study Sites (38)

Reunion Investigational Site

Birmingham, Alabama, 35209, United States

Location

Reunion Investigational Site

Tucson, Arizona, 85724, United States

Location

Reunion Investigational Site

Santa Monica, California, 90404, United States

Location

Reunion Investigational Site

Boulder, Colorado, 80045, United States

Location

Reunion Investigational Site

Denver, Colorado, 80209, United States

Location

Reunion Investigational Site

Lauderhill, Florida, 33319, United States

Location

Reunion Investigational Site

Tampa, Florida, 33613, United States

Location

Reunion Investigational Site

Atlanta, Georgia, 30329, United States

Location

Reunion Investigational Site

Atlanta, Georgia, 30331, United States

Location

Reunion Investigational Site

Decatur, Georgia, 30030, United States

Location

Reunion Investigational Site

Marietta, Georgia, 30060, United States

Location

Reunion Investigational Site

Savannah, Georgia, 31405, United States

Location

Reunion Investigational Site

Honolulu, Hawaii, 96817, United States

Location

Reunion Investigational Site

Kansas City, Kansas, 66160, United States

Location

Reunion Investigational Site

Shreveport, Louisiana, 71106, United States

Location

Reunion Investigational Site

Baltimore, Maryland, 21205, United States

Location

Reunion Investigational Site

Rockville, Maryland, 20850, United States

Location

Reunion Investigational Site

Springfield, Massachusetts, 01103, United States

Location

Reunion Investigational Site

Novi, Michigan, 48377, United States

Location

Reunion Investigational Site

Albuquerque, New Mexico, 87131, United States

Location

Reunion Investigational Site

Buffalo, New York, 14202, United States

Location

Reunion Investigational Site

New York, New York, 10016, United States

Location

Reunion Investigational Site

New York, New York, 10026, United States

Location

Reunion Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

Reunion Investigational Site

Monroe, North Carolina, 28112, United States

Location

Reunion Investigational Site

Cleveland, Ohio, 44113, United States

Location

Reunion Investigational Site

Columbus, Ohio, 43210, United States

Location

Reunion Investigational Site

West Chester, Pennsylvania, 19380, United States

Location

Reunion Investigational Site

Austin, Texas, 78712, United States

Location

Reunion Investigational Site

Austin, Texas, 78737, United States

Location

Reunion Investigational Site

Austin, Texas, 78759, United States

Location

Reunion Investigational Site

Plano, Texas, 75093, United States

Location

Reunion Investigational Site

San Antonio, Texas, 78229, United States

Location

Reunion Investigational Site

Draper, Utah, 84020, United States

Location

Reunion Investigational Site

Salt Lake City, Utah, 84108, United States

Location

Reunion Investigational Site

Charlottesville, Virginia, 22903, United States

Location

Reunion Investigational Site

Seattle, Washington, 98105, United States

Location

Reunion Investigational Site

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Injections

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jasna Hocevar-Trnka, M.D.

  Reunion Neuroscience Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: June 14, 2024
• Primary Completion: May 22, 2025
• Study Completion: June 16, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)