A Phase 2 interventional study of RE104 for Injection in Postpartum Depression, sponsored by Reunion Neuroscience Inc. Completed at 38 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Reunion Neuroscience Inc · Phase 2, Interventional, and Treatment
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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's enrollment of 84 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Reunion Neuroscience Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single subcutaneous injection of 1.5 mg RE104 for Injection
Drug: RE104 for Injection
A single subcutaneous injection of 30 mg RE104 for Injection
Drug: RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
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.
Time frame: Day 7
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 7
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).
Time frame: 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).
Time frame: Day 1, Day 7 and Day 28
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.
Time frame: Day 7
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.
Time frame: From dosing through study completion (post-dose follow-up is for 28 days)
Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
No publications or documents are linked to this record.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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