A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
Public ClinicalTrials.gov record NCT06285916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Placebo-Controlled, Double-Blinded, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Oral NORA520 in Female Adults With Severe Postpartum Depression
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine: * How well NORA520 is tolerated and what side effects it may cause * If NORA520 reduces depressive symptoms in subjects with severe PPD * The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken * In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.
Study identification
- NCT ID
- NCT06285916
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 93 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2024
- Primary completion
- Sep 10, 2025
- Completion
- Oct 5, 2025
- Last update posted
- Jul 30, 2026
2024 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 8
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | — |
| Advanced Research Center | Anaheim | California | 92805 | — |
| Alliance Research Institute | Canoga Park | California | 91304 | — |
| Cenexel Clinical Research | Sherman Oaks | California | 91403 | — |
| Cenexel Clinical Research | Torrance | California | 90504 | — |
| MedOne Clinical Research | Miami | Florida | 33145 | — |
| Meridian International Research, Inc. | Miami Gardens | Florida | 33014 | — |
| Combined Research | Orlando | Florida | 32807 | — |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | — |
| GCP Research | St. Petersburg | Florida | 33607 | — |
| Cenexel Clinical Research | Atlanta | Georgia | 30331 | — |
| CenExel Clinical Research | Decatur | Georgia | 30030 | — |
| CenExel Clinical Research | Savannah | Georgia | 31405 | — |
| Insight Hospital and Medical Center Chicago | Chicago | Illinois | 60616 | — |
| Zucker Hillside Hospital | Glen Oaks | New York | 11004 | — |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | — |
| Maximos Ob/Gyn | League City | Texas | 77573 | — |
| Pillar Clinical Researc | Richardson | Texas | 75080 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06285916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06285916 live on ClinicalTrials.gov.