Postpartum DepressionPhase 4NCT04273191
A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
A Phase 4 study testing Brexanolone in people with Postpartum Depression, run by Sage Therapeutics.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Brexanolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
About this study
Official title: An Evaluation of Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO
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.
- Conditions
- Postpartum Depression
- Being tested
- Brexanolone
- Keywords
- Postpartum Depression, ZULRESSO
- 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™, SAGE-547
Brexanolone will be initiated and administered per the USPI and the associated REMS.
| Study group | Role | What they receive |
|---|---|---|
| Brexanolone | Experimental | Participants will receive a single dose of commercial brexanolone as part of standard of care. Receives: Drug: Brexanolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 5 days
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.
Measured: Up to approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: Sage Therapeutics has decided not to proceed with this study at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sage Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273191
- Sponsor's protocol ID
- 547-EXM-401
- Status last verified
- Aug 2020
- First submitted
- 14 Feb 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO
- ClinicalTrials.gov ID
- NCT04273191
- Acronym / sponsor ID
- 547-EXM-401
- Conditions
- Postpartum Depression
- Keywords
- Postpartum Depression, ZULRESSO
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sage Therapeutics has decided not to proceed with this study at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sage TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brexanolone | Experimental | Drug: BrexanoloneParticipants will receive a single dose of commercial brexanolone as part of standard of care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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: ZULRESSO™, SAGE-547Brexanolone will be initiated and administered per the USPI and the associated REMS. | Drug | Brexanolone |
Primary outcome
Change from Baseline to Post-Infusion on the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score
Time frame: Up to approximately 5 days
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)
Time frame: Up to approximately 5 days
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Related trials for Postpartum Depression
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
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brexanolone in people with Postpartum Depression, run by Sage Therapeutics.
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 10 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: withdrawn, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from Baseline to Post-Infusion on the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score (time frame: Up to approximately 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2020.