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The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZULRESSO® | Experimental | Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZULRESSO® | Drug | Intravenous infusion of ZULRESSO®. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single decimal. | Up to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO® | Nonadherence was defined by failure of any of following:
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Inclusion Criteria:
Ambulatory female ≥18 years of age.
Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
Participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren).
Participant has no history of sleep apnea or any clinically significant respiratory conditions.
Participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.
Participant is suitable for administration of ZULRESSO® in a home setting, as per the judgement of the investigator.
Participant's home is suitable and has necessary provisions for administration of ZULRESSO® and meets the following criteria:
Participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency.
Participant must have a negative pregnancy test at screening and on Day 1 prior to the start of the ZULRESSO® infusion.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Investigational Site | Culver City | California | 90230 | United States | ||
| Virtual Site (recruiting nationwide) |
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov
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A total of 80 participants were screened, of which 52 were enrolled and 42 were treated.
Participants were enrolled at 5 active clinical sites in the United States from 08 October 2021 to 14 July 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | ZULRESSO® | Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set included all participants who were administered ZULRESSO®.
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| ID | Title | Description |
|---|---|---|
| BG000 | ZULRESSO® | Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single decimal. | Safety Set included all participants who were administered ZULRESSO®. | Posted | Number | percentage of participants | Up to Day 3 |
|
Up to Day 3
Safety Set included all participants who were administered ZULRESSO®.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ZULRESSO® | Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Sage Therapeutics | (617) 299-8380 | info@sagerx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2021 | Jun 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2022 | Jun 26, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000625635 | brexanolone |
| D011280 | Pregnanolone |
| ID | Term |
|---|---|
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Up to Day 3 |
| Number of Use-Related Issues Related to the Home Administration of ZULRESSO® | Home healthcare provider (HHP) staff completed checklists at end of each day and/or shift to document any use-related issues throughout duration of infusion. Any use-related issues determined to be critical in nature were followed up immediately and were reported adequately. Use-related issues were categorized as Critical Use Error (UE): HHP failed to complete a task or made uncorrected use error during task that could have resulted in harm, compromised medical care, incidence of nonadherence with safe use conditions for administration of ZULRESSO, or incidence of use-related issues related to home administration of ZULRESSO; Use Difficulty (UD): HHP successfully completed a task but did so while experiencing issues/operational difficulties; Close Call (CC): HHP committed error that could have led to a task failure, but self-corrected and completed task successfully. Multiple occurrences of issue throughout a single infusion was included only once in total. | Up to Day 3 |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to nearest single decimal. | Up to Day 3 |
| Percentage of Participants With Medication Error | Medication error was any preventable event that may cause or lead to inappropriate medication use or participant harm while the medication was in the control of the healthcare professional, participant, or consumer. Percentages are rounded off to the nearest single decimal. | At screening and during the study (Up to Day 3) |
| Culver City |
| California |
| 90230 |
| United States |
| Sage Investigational Site | Miramar | Florida | 33029 | United States |
| Sage Investigational Site | Pompano Beach | Florida | 33060 | United States |
| Sage Investigational Site | New York | New York | 10036 | United States |
| Sage Investigational Site | League City | Texas | 77573 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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|
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| Secondary | Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO® | Nonadherence was defined by failure of any of following:
| Safety Set included all participants who were administered ZULRESSO®. | Posted | Number | percentage of participants | Up to Day 3 |
|
|
|
| Secondary | Number of Use-Related Issues Related to the Home Administration of ZULRESSO® | Home healthcare provider (HHP) staff completed checklists at end of each day and/or shift to document any use-related issues throughout duration of infusion. Any use-related issues determined to be critical in nature were followed up immediately and were reported adequately. Use-related issues were categorized as Critical Use Error (UE): HHP failed to complete a task or made uncorrected use error during task that could have resulted in harm, compromised medical care, incidence of nonadherence with safe use conditions for administration of ZULRESSO, or incidence of use-related issues related to home administration of ZULRESSO; Use Difficulty (UD): HHP successfully completed a task but did so while experiencing issues/operational difficulties; Close Call (CC): HHP committed error that could have led to a task failure, but self-corrected and completed task successfully. Multiple occurrences of issue throughout a single infusion was included only once in total. | Safety Set included all participants who were administered ZULRESSO®. Overall number of units analyzed signifies total number of use related issues. | Posted | Count of Units | Issues | Up to Day 3 | Issues | Issues |
|
|
|
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to nearest single decimal. | Safety Set included all participants who were administered ZULRESSO®. | Posted | Number | percentage of participants | Up to Day 3 |
|
|
|
| Secondary | Percentage of Participants With Medication Error | Medication error was any preventable event that may cause or lead to inappropriate medication use or participant harm while the medication was in the control of the healthcare professional, participant, or consumer. Percentages are rounded off to the nearest single decimal. | Safety Set included all participants who were administered ZULRESSO®. | Posted | Number | percentage of participants | At screening and during the study (Up to Day 3) |
|
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|
| 0 |
| 42 |
| 0 |
| 42 |
| 15 |
| 42 |
| Infusion site pain | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|