Overview

A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)

Status:
Withdrawn
Trial end date:
2021-08-01
Target enrollment:
0
Participant gender:
Female
Summary
In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of care for postpartum depression (PPD) and who are planning to receive the infusion per United States Prescribing Information (USPI) at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare center are being asked to participate to collect data on multimodal neuroimaging parameters in order to evaluate the relationship between changes in depressive symptoms and changes in neuroimaging parameters.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sage Therapeutics
Treatments:
Brexanolone
Pregnanolone
Criteria
Inclusion criteria:

- Participant has been prescribed brexanolone for PPD and plans to receive commercially
available brexanolone per the USPI at a REMS-certified healthcare setting.

- Participant is ambulatory.

- Participant agrees to adhere to the study requirements.

- 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 the Diagnostic and Statistical Manual of Mental
Disorders (SCID-5).

- Participant agrees not to be the primary caregiver of any dependents during the
infusion.

- Participant has a HAM-D total score of ≥22 at screening and baseline.

- Participant is ≤12 months postpartum at screening.

- Participant is willing at screening to delay the start of any new pharmacotherapy
regimens, including antidepressant or antianxiety medication until the brexanolone
infusion and post-Infusion assessments have been completed. If medically justified,
any new medication should be delayed until after the Day 30 follow-up visit.

- If the participant is taking medications administered to treat the symptoms of
depression or anxiety (such as anxiolytics or antidepressants), these must be at a
stable dose from 30 days prior to dosing until the brexanolone infusion and
post-infusion assessments have been completed. If medically justified, any change of
preexisting medication should be delayed until after the Day 30 follow-up visit.

- Participant agrees to use a highly effective method of contraception during
participation in the study and for 30 days following the end of the brexanolone
infusion, unless she is surgically sterile (bilateral salpingectomy, bilateral
oophorectomy, and/or hysterectomy) or does not engage in sexual relations which carry
a risk of pregnancy.

Exclusion criteria:

- Participant has a positive pregnancy test at screening or baseline.

- Participant's most recent pregnancy resulted in a miscarriage, still birth, or
neonatal death; or participant has terminated parental rights (eg, child has been
placed for adoption).

- Participant has evidence of any gross brain abnormality observed during the baseline
MRI, as determined by a radiologist.

- Participant has clinically significant findings considered to interfere with the
participant's ability to safely participate in the study, as determined by the
investigator upon evaluation of medical history, electrocardiogram, hematology, and
clinical chemistry.

- Participant has end stage renal disease.

- Participant is in hepatic failure.

- Participant has known allergy to progesterone or allopregnanolone.

- Participant has active psychosis per investigator assessment.

- Participant has attempted suicide during the current episode of PPD.

- Participant has a medical history of bipolar disorder, schizophrenia, and/or
schizoaffective disorder.

- Participant has current/active alcohol or drug abuse (including benzodiazepines)
within the 30 days prior to screening as assessed by the investigator. A positive
urine drug screen is exclusionary unless deemed by the investigator to reflect a
prescribed medication.

- Participant has been exposed to an investigational medication or device within 30 days
prior to screening.

- During the current episode of PPD, participant has participated in this study or any
other study employing brexanolone, SAGE-217, ganaxolone, or a similar compound, or has
received prior treatment with ZULRESSO™.

- Participant is investigative site personnel, sponsor personnel, or an immediate member
of their family (spouse, parent, child, or sibling, whether biological or legally
adopted).

- Participant has received electroconvulsive therapy within 30 days prior to screening
and/or plans to receive electroconvulsive therapy before the Day 30 visit.

- MRI is contraindicated for the participant for any reason, including but not limited
to: cardiac pacemaker, surgical implants, previous accident resulting in metal or
shrapnel lodged internally, tattoos inked with metallic dyes, a history of metal work
without using protective eyewear, history of claustrophobia.