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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Withdrawn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
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postpartum Depression focused on measuring Postpartum Depression, ZULRESSO

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    February 14, 2020
    Last Updated
    August 14, 2020
    Sponsor
    Sage Therapeutics
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    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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