Trial · NCT05059600
A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
NCT05059600, Phase 4, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2023-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting. Trials, record NCT05059600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05059600
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
- NCT number
- NCT05059600
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 52 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Postpartum Depression
- Interventions
- ZULRESSO®
- First posted
- 2021-09-28
- Last updated
- 2025-09-15
- Results first posted
- 2023-07-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation | Up to Day 3 | 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. |
| Secondary | Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO® | Up to Day 3 | Nonadherence was defined by failure of any of following: * Home infusion provider to train all pharmacy and home healthcare providers (HHPs) in dispensing/administration of ZULRESSO® on risk of excessive sedation/loss of consciousness * HHPs to counsel participants on risk of excessive sedation/loss of consciousness * Deliver ZULRESSO® per protocol * Provide preprogrammed peristaltic pump * HHP:assess excessive sedation every 2 hours in planned nonsleep periods, change infusion bag per protocol, at least one HHP available in participant's home for the duration of infusion * Fall protocol in place * Monitor participants with pulse oximeter * Stop infusion when participant is primary caregiver of dependents and/or identification of excessive sedation/loss of consciousness/hypoxic episode * Caution participants post-infusion against engaging in hazardous activities requiring mental alertness * Complete AE of special interest/Serious AE form * Infusion resumed after hypoxia episode |
| Secondary | Number of Use-Related Issues Related to the Home Administration of ZULRESSO® | Up to Day 3 | 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. |
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 3 | 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. |
| Secondary | Percentage of Participants With Medication Error | At screening and during the study (Up to Day 3) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation | Up to Day 3 | Safety Set included all participants who were administered ZULRESSO®. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO® | Up to Day 3 | Safety Set included all participants who were administered ZULRESSO®. | percentage of participants | NUMBER |
| SECONDARY | Number of Use-Related Issues Related to the Home Administration of ZULRESSO® | Up to Day 3 | Safety Set included all participants who were administered ZULRESSO®. Overall number of units analyzed signifies total number of use related issues. | Issues | COUNT_OF_UNITS |
| SECONDARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 3 | Safety Set included all participants who were administered ZULRESSO®. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Medication Error | At screening and during the study (Up to Day 3) | Safety Set included all participants who were administered ZULRESSO®. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation | ZULRESSO® | 7.1 | percentage of participants | ||
| Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO® | ZULRESSO® | 76.19 | percentage of participants | ||
| Number of Use-Related Issues Related to the Home Administration of ZULRESSO® | ZULRESSO® | Critical Use Errors (UE) | 13 | Issues | |
| Number of Use-Related Issues Related to the Home Administration of ZULRESSO® | ZULRESSO® | Use Difficulties (UD) | 62 | Issues | |
| Number of Use-Related Issues Related to the Home Administration of ZULRESSO® | ZULRESSO® | Close Calls (CC) | 0 | Issues | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | ZULRESSO® | 42.9 | percentage of participants | ||
| Percentage of Participants With Medication Error | ZULRESSO® | At Screening | 28.6 | percentage of participants | |
| Percentage of Participants With Medication Error | ZULRESSO® | During the Study (Up to Day 3) | 54.8 | percentage of participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ZULRESSO® | 52 | |
| Overall Study | Treated | ZULRESSO® | 42 | |
| Overall Study | COMPLETED | ZULRESSO® | 42 | |
| Overall Study | NOT COMPLETED | ZULRESSO® | 10 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | ZULRESSO® | 5 | 42 | |
| other | Infusion site pain | General disorders | ZULRESSO® | 3 | 42 | |
| other | Headache | Nervous system disorders | ZULRESSO® | 4 | 42 | |
| other | Somnolence | Nervous system disorders | ZULRESSO® | 3 | 42 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZULRESSO® | 0 | 42 |
| Total, other adverse events | ZULRESSO® | 15 | 42 |
| Total, serious adverse events | ZULRESSO® | 0 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05059600
GET https://conductscience.org/api/trials/v1/NCT05059600/registered