Postpartum DepressionBRX-PPDNCT05543746
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
An observational study of Postpartum Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Brexanolone
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 15 Nov 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- Meets DSM-V criteria for major depressive disorder with peripartum onset.
- 17-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
Who cannot join
- 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
Show all 16Show fewer
- 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
- On benzodiazepines
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression: a Feasibility Study
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
- Being tested
- Brexanolone
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexanoloneDrug
Also called Zulresso
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Successfully Analyzed EEG Recordings
Feasibility of EEG recordings. Each participant was scheduled to have 5 EEG recordings.
Measured: 4 days
Number of Subjects Completing the Entire Study Protocol Through the Follow-up Phase
Feasibility of study completion
Measured: 30 days
Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden
Feasibility of subject burden
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start5 Aug 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Baszucki Brain Research Fund, Sage Therapeutics
- Responsible party
- Sponsor
- Investigators
- Susan Girdler, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543746
- Sponsor's protocol ID
- 21-2224
- Acronym
- BRX-PPD
- Status last verified
- Dec 2024
- First submitted
- 13 Sep 2022
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kozik R, Patterson R, Andersen E, Putnam FW, Rubinow D. Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression. J Clin Psychiatry. 2026 Mar 11;87(2):25m16144. doi: 10.4088/JCP.25m16144.
PubMed 41871269
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05543746
- Acronym / sponsor ID
- BRX-PPD / 21-2224
- Conditions
- Postpartum Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Baszucki Brain Research Fund, Sage Therapeutics
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexanoloneAlso: ZulressoEnrolled 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. | Drug | – |
Primary outcome
Number of Successfully Analyzed EEG Recordings
Time frame: 4 days
Feasibility of EEG recordings. Each participant was scheduled to have 5 EEG recordings.
Number of Subjects Completing the Entire Study Protocol Through the Follow-up Phase
Time frame: 30 days
Feasibility of study completion
Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden
Time frame: 30 days
Feasibility of subject burden
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41871269Kozik R, Patterson R, Andersen E, Putnam FW, Rubinow D. Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression. J Clin Psychiatry. 2026 Mar 11;87(2):25m16144. doi: 10.4088/JCP.25m16144.
Related trials for Postpartum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Girdler, PhD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Successfully Analyzed EEG Recordings (time frame: 4 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05543746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.