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

NCT05543746 | Completed Results FDA Drug

• 1 other identifier: 21-2224
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility study of performing repeated EEG recordings and assessment of affective states during open-label administration of BRX to women with postpartum depression. Study phases will include screening, enrollment, intervention, and follow-up. Subjects will be screened for study eligibility criteria through clinical assessments and self-report. Enrolled subjects will be admitted to the UNC Women's Hospital, where five serial EEG recordings will be obtained, along with frequent assessments of affective state, before, during, and after a 60-hour IV infusion of BRX. Follow-up procedures will include assessments of PPD and affective symptoms, as well as an exit interview with the study team. If feasibility outcomes are achieved, exploratory EEG analyses will be performed with AMICA (adaptive mixture independent component analysis), community detection, and microstate assessment. Exploratory analyses of data collected by facial expression detection software (iMotions Affectiva) are also planned.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (3)

• Number of Successfully Analyzed EEG Recordings

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

  4 days

• Number of Subjects Completing the Entire Study Protocol Through the Follow-up Phase

  Feasibility of study completion

  30 days

• Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden

  Feasibility of subject burden

  30 days

Interventions

Brexanolone DRUG

Enrolled subjects will receive a 60-hour infusion of Brexanolone (BRX) according to FDA approved protocol for administration. A programmable peristaltic infusion pump will be used to ensure accurate delivery.

Also known as: Zulresso

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with moderate to severe PPD, medically eligible to receive FDA-approved BRX infusion, recruited from current inpatient and outpatient population in the Women's Mood Disorders Clinic at UNC and through local advertisements. Subjects recruited from outpatient setting will be individuals for whom BRX is the chosen recommended course of treatment.

You may qualify if:

• Signed informed consent.
• Documented proof of full COVID-19 vaccination
• Ambulatory, female, aged 18-45
• ≤ 8 months postpartum
• Agrees to adhere to the study requirements.
• Onset of depression in 3rd trimester or within 4 weeks of delivery
• Meets DSM-V criteria for major depressive disorder with peripartum onset.
• item HAM-D total score ≥20 at screening
• Stopped breastfeeding or agrees to temporarily stop for 7 days including 4 days of hospitalization and 3 days after
• No new psychotropic drugs during screening and active treatment of study
• Stable use of any current psychotropic drugs for at least 28 days prior to enrollment, with stable dosage for at least 14 days prior to enrollment
• Must be on documented contraceptive.
• Must have a caregiver or family member with them to help care for the subject's child(ren) during the infusion and to be in the room with the subject if the child(ren) are present during the infusion

You may not qualify if:

• Positive pregnancy test at screening or day 1
• Pregnancy that resulted in a stillbirth, termination, or child that was placed for adoption.
• Renal impairment or failure, hepatic impairment or failure, or anemia
• Untreated or inadequately treated hypothyroidism or hyperthyroidism
• Known allergy to progesterone or allopregnanolone.
• Suicide attempt at this episode
• Medical history of schizophrenia, and/or schizoaffective disorder
• Current psychotic symptoms including delusions, hallucinations, or formal thought disorder.
• Concurrent substance abuse
• Exposure to another investigational medication or device within 30 days
• Has previously participated in any study employing brexanolone or SAGE-217.
• Subject is investigative site personnel, sponsor personnel, or an immediate member of their family.
• Has received electroconvulsive therapy during current episode.
• History of seizure disorder
• On anticonvulsant agents

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Baszucki Brain Research Fund: collaborator
• Sage Therapeutics: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

brexanolone

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rachel Kozik
• Organization: University of North Carolina at Chapel Hill

rachel_kozik@med.unc.edu

919-590-0813

Study Officials

• Susan Girdler, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: August 5, 2022
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: January 28, 2025
• Results First Posted: January 28, 2025

Record last verified: 2024-12

Locations

US (1)