Trial Outcomes & Findings for Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression (NCT NCT05543746)

NCT ID: NCT05543746

Last Updated: 2025-01-28

Results Overview

Feasibility of EEG recordings. Each participant was scheduled to have 5 EEG recordings.

• Recruitment status: COMPLETED
• Target enrollment: 10 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2025-01-28

Participant Flow

Participant milestones

Measure	Brexanolone Based on an FDA-approved regimen, the 60-hour infusion was administered as follows: 30 mcg/kg/hour (Hour 0 to 4), then 60 mcg/kg/hour (Hour 4 to 24), then 90 mcg/kg/hour (Hour 24 to 52), followed by 60 mcg/kg/hour (Hour 52 to 56), and 30 mcg/kg/hour (Hour 56 to 60).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

Baseline characteristics by cohort

Measure	Brexanolone n=10 Participants Based on an FDA-approved regimen, the 60-hour infusion was administered as follows: 30 mcg/kg/hour (Hour 0 to 4), then 60 mcg/kg/hour (Hour 4 to 24), then 90 mcg/kg/hour (Hour 24 to 52), followed by 60 mcg/kg/hour (Hour 52 to 56), and 30 mcg/kg/hour (Hour 56 to 60).
Age, Continuous	33 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Feasibility of EEG recordings. Each participant was scheduled to have 5 EEG recordings.

Outcome measures

Measure	Brexanolone n=10 Participants Based on an FDA-approved regimen, the 60-hour infusion was administered as follows: 30 mcg/kg/hour (Hour 0 to 4), then 60 mcg/kg/hour (Hour 4 to 24), then 90 mcg/kg/hour (Hour 24 to 52), followed by 60 mcg/kg/hour (Hour 52 to 56), and 30 mcg/kg/hour (Hour 56 to 60).
Number of Successfully Analyzed EEG Recordings	49 EEG recordings

PRIMARY outcome

Timeframe: 30 days

Feasibility of study completion

Outcome measures

Measure	Brexanolone n=10 Participants Based on an FDA-approved regimen, the 60-hour infusion was administered as follows: 30 mcg/kg/hour (Hour 0 to 4), then 60 mcg/kg/hour (Hour 4 to 24), then 90 mcg/kg/hour (Hour 24 to 52), followed by 60 mcg/kg/hour (Hour 52 to 56), and 30 mcg/kg/hour (Hour 56 to 60).
Number of Subjects Completing the Entire Study Protocol Through the Follow-up Phase	10 Participants

PRIMARY outcome

Timeframe: 30 days

Feasibility of subject burden

Outcome measures

Measure	Brexanolone n=10 Participants Based on an FDA-approved regimen, the 60-hour infusion was administered as follows: 30 mcg/kg/hour (Hour 0 to 4), then 60 mcg/kg/hour (Hour 4 to 24), then 90 mcg/kg/hour (Hour 24 to 52), followed by 60 mcg/kg/hour (Hour 52 to 56), and 30 mcg/kg/hour (Hour 56 to 60).
Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden	0 Participants

Adverse Events

Brexanolone

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Brexanolone n=10 participants at risk Based on an FDA-approved regimen, the 60-hour infusion was administered as follows: 30 mcg/kg/hour (Hour 0 to 4), then 60 mcg/kg/hour (Hour 4 to 24), then 90 mcg/kg/hour (Hour 24 to 52), followed by 60 mcg/kg/hour (Hour 52 to 56), and 30 mcg/kg/hour (Hour 56 to 60).
Nervous system disorders Dizziness	40.0% 4/10 • Number of events 4 • From first dose of study drug up to end of follow-up period (up to Day 30)
General disorders Fatigue	30.0% 3/10 • Number of events 3 • From first dose of study drug up to end of follow-up period (up to Day 30)
General disorders Dry mouth	20.0% 2/10 • Number of events 2 • From first dose of study drug up to end of follow-up period (up to Day 30)
Nervous system disorders Headache	30.0% 3/10 • Number of events 4 • From first dose of study drug up to end of follow-up period (up to Day 30)
General disorders Infusion site bruising	20.0% 2/10 • Number of events 2 • From first dose of study drug up to end of follow-up period (up to Day 30)
General disorders Infusion site pain	20.0% 2/10 • Number of events 2 • From first dose of study drug up to end of follow-up period (up to Day 30)
Vascular disorders Flushing	40.0% 4/10 • Number of events 4 • From first dose of study drug up to end of follow-up period (up to Day 30)
Psychiatric disorders Difficulty concentrating	10.0% 1/10 • Number of events 1 • From first dose of study drug up to end of follow-up period (up to Day 30)

Additional Information

Rachel Kozik

University of North Carolina at Chapel Hill

Phone: 919-590-0813

Email: rachel_kozik@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place