Clinical trial NCT06057012: A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Postpartum Depression
Keywords: Treatment
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of study drug up to Day 45
measure: Number of Participants With Adverse Events (AEs) According to Severity
timeFrame: From the first dose of study drug up to Day 45
measure: Number of Participants With Change From Baseline in Clinically Significant Vital Sign Parameters
timeFrame: Baseline up to Day 45
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Parameters
timeFrame: From the first dose of study drug up to Day 45
measure: Number of Participants With Change From Baseline in Clinically Significant Clinical Laboratory Evaluations
timeFrame: From the first dose of study drug up to Day 45
measure: Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Responses
timeFrame: Baseline up to Day 45
measure: Change From Baseline in Glasgow Coma Scale (GCS) Score
timeFrame: Baseline up to Day 45
measure: Change From Baseline in Stanford Sleepiness Scale (SSS) Score
timeFrame: Baseline up to Day 45
measure: PK of Brexanolone: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1- Day 45
measure: PK of Brexanolone: Time to Reach Cmax (Tmax)
timeFrame: Day 1- Day 45
measure: PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last)
timeFrame: Day 1- Day 45
measure: PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf)
timeFrame: Day 1- Day 45
measure: PK of Brexanolone: Apparent Terminal Elimination Half-life (t½)
timeFrame: Day 1- Day 45
measure: PK of Brexanolone: Apparent Clearance (CL/F)
timeFrame: Day 1- Day 45
measure: PK of Brexanolone: Volume of Distribution (Vz/F)
timeFrame: Day 1- Day 45
Secondary outcomes:
measure: Change From Baseline in Hamilton Depression Rating Scale (HAM-D) Total Score
timeFrame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
measure: Number of Participants With HAM-D Response
timeFrame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
measure: Number of Participants With HAM-D Remission
timeFrame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
measure: Number of Participants With Clinical Global Impression - Improvement (CGI-I) Response
timeFrame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Response
timeFrame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
measure: Change From Baseline in HAM-D Bech-6 Subscale Score
timeFrame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
measure: Change From Baseline in HAM-D Individual Item Score
timeFrame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
timeFrame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Other outcomes:
Locations:
city: Sherman Oaks
country: United States
facility: Cenexel CNR
state: California
city: Torrance
country: United States
facility: CenExel CNS-Torrance
state: California
city: Boynton Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Davie
country: United States
facility: Aventura Clinical Research, LLC
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV Inc
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Cenexel ACMR Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Denver
country: United States
facility: Research Carolina Elite
state: North Carolina
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: League City
country: United States
facility: Maximos OB/GYN
state: Texas
Study officials:
References: