A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
Primary Purpose
Postpartum Depression
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brexanolone
Sponsored by
About this trial
This is an interventional other trial for Postpartum Depression focused on measuring Postpartum Depression, ZULRESSO
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brexanolone
Arm Description
Participants will receive a single dose of commercial brexanolone as part of standard of care.
Outcomes
Primary Outcome Measures
Change from Baseline to Post-Infusion on the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score
The HAM-D total score comprises a sum of 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early night, middle night, early morning), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items scored in a range of 0 to 4 include: agitation, depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52.
Change from Baseline to Post-Infusion in Functional Connectivity Using Blood Oxygenation Level-Dependent (BOLD) Resting State Functional Magnetic Resonance Imaging (rsfMRI)
rsfMRI is used in brain mapping to evaluate regional interactions that occur in a resting or task-negative state, when an explicit task is not being performed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04273191
Brief Title
A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
Official Title
An Evaluation of Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Sage Therapeutics has decided not to proceed with this study at this time
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Postpartum Depression, ZULRESSO
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brexanolone
Arm Type
Experimental
Arm Description
Participants will receive a single dose of commercial brexanolone as part of standard of care.
Intervention Type
Drug
Intervention Name(s)
Brexanolone
Other Intervention Name(s)
ZULRESSO™, SAGE-547
Intervention Description
Brexanolone will be initiated and administered per the USPI and the associated REMS.
Primary Outcome Measure Information:
Title
Change from Baseline to Post-Infusion on the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score
Description
The HAM-D total score comprises a sum of 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early night, middle night, early morning), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items scored in a range of 0 to 4 include: agitation, depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52.
Time Frame
Up to approximately 5 days
Title
Change from Baseline to Post-Infusion in Functional Connectivity Using Blood Oxygenation Level-Dependent (BOLD) Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Description
rsfMRI is used in brain mapping to evaluate regional interactions that occur in a resting or task-negative state, when an explicit task is not being performed.
Time Frame
Up to approximately 5 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Learn more about this trial
A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
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