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NCT06285916 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
A Phase 2 study of Postpartum Depression and Depression, Postpartum, sponsored by DuKang Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 18
- Study locations
NCT06285916: Completed Phase 2 study of Postpartum Depression and Depression, Postpartum, sponsored by DuKang Pharmaceuticals.
NCT06285916 is a Phase 2 study of Postpartum Depression and Depression, Postpartum that has completed, run by DuKang Pharmaceuticals. The registered enrollment target is 93 participants, below the 473-participant average among 47 other Postpartum Depression trials with a reported enrollment target (80% lower). The trial reports 18 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06285916, a Phase 2 study of Postpartum Depression and Depression, Postpartum, has completed, sponsored by DuKang Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 18
- Study locations
Study Summary
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.
Primary Outcome
Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NORA520 Dose 1
- DRUG NORA520 Dose 2
Study Locations (18)
Florida
- MedOne Clinical Research - Miami
- Meridian International Research, Inc. - Miami Gardens
- Combined Research - Orlando
- Clinical Research Center of Florida - Pompano Beach
- GCP Research - St. Petersburg
California
- Advanced Research Center - Anaheim
- Alliance Research Institute - Canoga Park
- Cenexel Clinical Research - Sherman Oaks
- Cenexel Clinical Research - Torrance
Georgia
- Cenexel Clinical Research - Atlanta
- CenExel Clinical Research - Decatur
- CenExel Clinical Research - Savannah
Texas
- Maximos Ob/Gyn - League City
- Pillar Clinical Researc - Richardson
Arkansas
- Pillar Clinical Research - Bentonville
Illinois
- Insight Hospital and Medical Center Chicago - Chicago
New York
- Zucker Hillside Hospital - Glen Oaks
North Carolina
- Monroe Biomedical Research - Monroe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2025-10-06 |
| Phase | Phase 2 |
What the finished NCT06285916 record still lists
NCT06285916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 473-participant average among 47 other Postpartum Depression trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06285916 lists 18 locations in 8 states (Florida, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT06285916 about?
NCT06285916 is a clinical study titled "A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression". 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...
What is the current status of trial NCT06285916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2024-03-28. Estimated completion is 2025-10-06.
What conditions does trial NCT06285916 study?
This clinical trial studies the following conditions: Postpartum Depression, Depression, Postpartum, Post-Natal Depression.
What interventions are being tested in trial NCT06285916?
The interventions under investigation include: Placebo (DRUG), NORA520 Dose 1 (DRUG), NORA520 Dose 2 (DRUG).
Who is sponsoring clinical trial NCT06285916?
This trial is sponsored by DuKang Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06285916 being conducted?
This trial has 18 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06285916's enrollment target sits among peer trials
93 26th of 47 higher than 22 of 47 other Postpartum Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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