Trial · NCT07398469
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
NCT07398469, Recruiting, Biogen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone. Trials, record NCT07398469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07398469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
- NCT number
- NCT07398469
- Status
- Recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Biogen
- Conditions
- Postpartum Depression
- Interventions
- Zuranolone
- First posted
- 2026-02-10
- Last updated
- 2026-09-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15 | Baseline (Day 0), Day 15 | EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms. |
| Secondary | Change From Baseline in the EPDS Score | Baseline (Day 0), Days 3 (Cohort 2 only), 45 and 90 | EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms. |
| Secondary | Change From Baseline in the EPDS Score in Participants With Moderate Severity | Baseline (Day 0), Days 3 (Cohort 2 only), 15, 45 and 90 | EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms. |
| Secondary | Change From Baseline in the EPDS by Baseline Severity | Baseline up to Day 90 | EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms. |
| Secondary | Number of Participants With no New Initiation of Medication After Completion of Zuranolone | At Days 45 and 90 | This outcome measure will be self-reported by participants. |
| Secondary | Number of Participants who Report no New Initiation of Treatment After Completion of Zuranolone by Severity | At Days 45 and 90 | This outcome measure will be self-reported by participants. |
| Secondary | Number of Participants Feeding Their Baby Breastmilk as Usual While Taking Zuranolone | At Day 45 | This outcome measure will be self-reported by participants. |
| Secondary | Number of Participants Achieving Remission | At Days 15, Day 45, and Day 90 | |
| Secondary | Number of Participants Achieving Remission by Baseline Severity | At Days 15, Day 45, and Day 90 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT07398469
GET https://conductscience.org/api/trials/v1/NCT07398469/registered