Postpartum Depression
Conditions
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.
Interventions
DRUGBrexanolone
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.
Sponsors
Baszucki Brain Research Fund
Sage Therapeutics
University of North Carolina, Chapel Hill
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * 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
Exclusion criteria
* 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 * On benzodiazepines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successfully Analyzed EEG Recordings | 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 | 30 days | Feasibility of study completion |
| Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden | 30 days | Feasibility of subject burden |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Brexanolone |
|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Subjects Completing the Entire Study Protocol Through the Follow-up Phase
Feasibility of study completion
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brexanolone | Number of Subjects Completing the Entire Study Protocol Through the Follow-up Phase | 10 Participants |
Primary
Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden
Feasibility of subject burden
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brexanolone | Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden | 0 Participants |
Primary
Number of Successfully Analyzed EEG Recordings
Feasibility of EEG recordings. Each participant was scheduled to have 5 EEG recordings.
Time frame: 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brexanolone | Number of Successfully Analyzed EEG Recordings | 49 EEG recordings |