A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
Public ClinicalTrials.gov record NCT06057012. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Descriptive Efficacy of BRII-296 in Adults With Severe Postpartum Depression (PPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to evaluate the safety and tolerability of BRII-296 administered by 2 intramuscular injections, administered with Depo Medrol as assessed by the incidence of adverse events, changes from baseline in vital signs, pulse oximetry, clinical laboratory evaluations, electrocardiograms (ECGs), Stanford Sleepiness Scale (SSS), Glasgow Coma Scale (GCS) in conjunction with clinical assessment, and suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS).
Study identification
- NCT ID
- NCT06057012
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 11 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 28, 2023
- Primary completion
- Mar 12, 2024
- Completion
- Mar 12, 2024
- Last update posted
- Jan 26, 2025
2023 – 2024
United States locations
- U.S. sites
- 11
- U.S. states
- 5
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cenexel CNR | Sherman Oaks | California | 91403 | — |
| CenExel CNS-Torrance | Torrance | California | 90504 | — |
| Clinical Research Center of Florida | Boynton Beach | Florida | 33435 | — |
| Aventura Clinical Research, LLC | Davie | Florida | 33328 | — |
| South Florida Research Phase I-IV Inc | Miami Springs | Florida | 33166 | — |
| Synexus Clinical Research US, Inc. | Atlanta | Georgia | 30328 | — |
| Cenexel ACMR Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| Research Carolina Elite | Denver | North Carolina | 28037 | — |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | — |
| Maximos OB/GYN | League City | Texas | 77573 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06057012, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 26, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06057012 live on ClinicalTrials.gov.