RE104 Safety and Efficacy Study in Postpartum Depression
NCT ID: NCT06342310
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2024-06-14
2025-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1.5 mg RE104
A single subcutaneous injection of 1.5 mg RE104 for Injection
RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
30 mg RE104
A single subcutaneous injection of 30 mg RE104 for Injection
RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
Interventions
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RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Reunion Neuroscience Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jasna Hocevar-Trnka, M.D.
Role: STUDY_DIRECTOR
Reunion Neuroscience Inc
Locations
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Reunion Investigational Site
Birmingham, Alabama, United States
Reunion Investigational Site
Tucson, Arizona, United States
Reunion Investigational Site
Santa Monica, California, United States
Reunion Investigational Site
Boulder, Colorado, United States
Reunion Investigational Site
Denver, Colorado, United States
Reunion Investigational Site
Lauderhill, Florida, United States
Reunion Investigational Site
Tampa, Florida, United States
Reunion Investigational Site
Atlanta, Georgia, United States
Reunion Investigational Site
Atlanta, Georgia, United States
Reunion Investigational Site
Decatur, Georgia, United States
Reunion Investigational Site
Marietta, Georgia, United States
Reunion Investigational Site
Savannah, Georgia, United States
Reunion Investigational Site
Honolulu, Hawaii, United States
Reunion Investigational Site
Kansas City, Kansas, United States
Reunion Investigational Site
Shreveport, Louisiana, United States
Reunion Investigational Site
Baltimore, Maryland, United States
Reunion Investigational Site
Rockville, Maryland, United States
Reunion Investigational Site
Springfield, Massachusetts, United States
Reunion Investigational Site
Novi, Michigan, United States
Reunion Investigational Site
Albuquerque, New Mexico, United States
Reunion Investigational Site
Buffalo, New York, United States
Reunion Investigational Site
New York, New York, United States
Reunion Investigational Site
New York, New York, United States
Reunion Investigational Site
Chapel Hill, North Carolina, United States
Reunion Investigational Site
Monroe, North Carolina, United States
Reunion Investigational Site
Cleveland, Ohio, United States
Reunion Investigational Site
Columbus, Ohio, United States
Reunion Investigational Site
West Chester, Pennsylvania, United States
Reunion Investigational Site
Austin, Texas, United States
Reunion Investigational Site
Austin, Texas, United States
Reunion Investigational Site
Austin, Texas, United States
Reunion Investigational Site
Plano, Texas, United States
Reunion Investigational Site
San Antonio, Texas, United States
Reunion Investigational Site
Draper, Utah, United States
Reunion Investigational Site
Salt Lake City, Utah, United States
Reunion Investigational Site
Charlottesville, Virginia, United States
Reunion Investigational Site
Seattle, Washington, United States
Reunion Investigational Site
Madison, Wisconsin, United States
Countries
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Other Identifiers
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RE104-201-PPD
Identifier Type: -
Identifier Source: org_study_id
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