RE104 Safety and Efficacy Study in Postpartum Depression
Purpose
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.
Condition
- Postpartum Depression
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 1.5 mg RE104 |
A single subcutaneous injection of 1.5 mg RE104 for Injection |
|
|
Experimental 30 mg RE104 |
A single subcutaneous injection of 30 mg RE104 for Injection |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Reunion Neuroscience Inc
