Status:
COMPLETED
A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
Lead Sponsor:
Brii Biosciences Limited
Conditions:
Severe Postpartum Depression
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
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 adver...
Eligibility Criteria
Inclusion
- Participant either must have ceased lactating at screening or is still lactating actively breastfeeding at screening , must agree temporarily cease giving breast milk to her infant(s)
- Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Participant was \<12 months postpartum
- Participant is amenable to intramuscular administration of investigational product on Day 1 and remaining inpatient until at least Day 4
Exclusion
- Active psychosis
- Attempted suicide associated with current episode of postpartum depression
- Medical history of seizures
- Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Key Trial Info
Start Date :
September 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06057012
Start Date
September 29 2023
End Date
March 13 2024
Last Update
January 27 2025
Active Locations (11)
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1
Cenexel CNR
Sherman Oaks, California, United States, 91403
2
CenExel CNS-Torrance
Torrance, California, United States, 90504
3
Clinical Research Center of Florida
Boynton Beach, Florida, United States, 33435
4
Aventura Clinical Research, LLC
Davie, Florida, United States, 33328