A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)

NCT06057012 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BRII-296-002
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 11

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).

Conditions

Severe Postpartum Depression

Keywords

Treatment

Outcome Measures

Primary Outcomes (15)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From the first dose of study drug up to Day 45

• Number of Participants With Adverse Events (AEs) According to Severity

  Severity will be assessed according to the following scale: Mild, moderate and severe.

  From the first dose of study drug up to Day 45

• Number of Participants With Change From Baseline in Clinically Significant Vital Sign Parameters

  Baseline up to Day 45

• Number of Participants With Abnormal Electrocardiogram (ECG) Parameters

  From the first dose of study drug up to Day 45

• Number of Participants With Change From Baseline in Clinically Significant Clinical Laboratory Evaluations

  From the first dose of study drug up to Day 45

• Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Responses

  The suicidal ideation and behavior will be monitored during the study using the C-SSRS. This scale consists of a "Baseline/Screening" version that assesses the lifetime and recent experience of the participant with suicidal ideation and behavior, and a "Since Last Visit" version that focuses on suicidality since the last study visit. The C-SSRS includes "yes" or "no" responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).

  Baseline up to Day 45

• Change From Baseline in Glasgow Coma Scale (GCS) Score

  The GCS is a simple measure of the depth and duration of impaired consciousness and coma. 3 domains of alertness will be evaluated: eye opening response (scored 1 \[None\] to 4 \[Spontaneous\]), verbal response (scored 1 \[None\] to 5 \[Oriented\]), and motor response (scored 1 \[None\] to 6 \[Obeys commands\]). Total scores range from 3 to 15, with 15 reflecting full alertness.

  Baseline up to Day 45

• Change From Baseline in Stanford Sleepiness Scale (SSS) Score

  The SSS is a participant-rated measure of sleepiness, frequently used for both research and clinical purposes. The SSS evaluates sleepiness at specific moments in time. Respondents rate their current degree of sleepiness and alertness on a scale of 1 to 7, where the lowest score of '1' indicates the respondent is 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicates the respondent is 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'.

  Baseline up to Day 45

• PK of Brexanolone: Maximum Observed Plasma Concentration (Cmax)

  Day 1- Day 45

• PK of Brexanolone: Time to Reach Cmax (Tmax)

  Day 1- Day 45

• PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last)

  Day 1- Day 45

• PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf)

  Day 1- Day 45

• PK of Brexanolone: Apparent Terminal Elimination Half-life (t½)

  Day 1- Day 45

• PK of Brexanolone: Apparent Clearance (CL/F)

  Day 1- Day 45

• PK of Brexanolone: Volume of Distribution (Vz/F)

  Day 1- Day 45

Secondary Outcomes (8)

• Change From Baseline in Hamilton Depression Rating Scale (HAM-D) Total Score

  Baseline and at Days 2, 3, 4, 8, 15, 30, and 45

• Number of Participants With HAM-D Response

  Baseline and at Days 2, 3, 4, 8, 15, 30, and 45

• Number of Participants With HAM-D Remission

  Baseline and at Days 2, 3, 4, 8, 15, 30, and 45

• Number of Participants With Clinical Global Impression - Improvement (CGI-I) Response

  Baseline and at Days 2, 3, 4, 8, 15, 30, and 45

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Response

  Baseline and at Days 2, 3, 4, 8, 15, 30, and 45

Study Arms (1)

BRII-296 + Depo Medrol

EXPERIMENTAL

Participants will receive BRII-296 600 milligram (mg) and Depo Medrol (80 milligram per milliliter \[mg/mL\]) on Day 1 as a combination therapy.

Drug: BRII-296; Drug: Depo Medrol

Interventions

BRII-296 DRUG

BRII-296 will be given via intramuscular injection.

BRII-296 + Depo Medrol

Depo Medrol DRUG

Depo Medrol will be given via intramuscular injection.

BRII-296 + Depo Medrol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brii Biosciences Limited: lead

Study Sites (11)

Cenexel CNR

Sherman Oaks, California, 91403, United States

Location

CenExel CNS-Torrance

Torrance, California, 90504, United States

Location

Clinical Research Center of Florida

Boynton Beach, Florida, 33435, United States

Location

Aventura Clinical Research, LLC

Davie, Florida, 33328, United States

Location

South Florida Research Phase I-IV Inc

Miami Springs, Florida, 33166, United States

Location

Synexus Clinical Research US, Inc.

Atlanta, Georgia, 30328, United States

Location

Cenexel ACMR Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Research Carolina Elite

Denver, North Carolina, 28037, United States

Location

North Texas Clinical Trials

Fort Worth, Texas, 76104, United States

Location

Maximos OB/GYN

League City, Texas, 77573, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: September 29, 2023
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

US (11)