A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
Completed · Phase 2 · Has a placebo group
Conditions studied: Depression, Postpartum, Postpartum Depression, Post-partum Depression, Postnatal Depression, Post-Natal Depression
In brief
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.
Key facts
- Study ID
- NCT06285916
- Run by
- TWi Biotechnology, Inc.
- People needed
- 93
- Starts
- 2024-03-28
- Expected to finish
- 2025-10-06
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Pillar Clinical Research — Bentonville, Arkansas, United States
- Advanced Research Center — Anaheim, California, United States
- Alliance Research Institute — Canoga Park, California, United States
- Cenexel Clinical Research — Sherman Oaks, California, United States
- Cenexel Clinical Research — Torrance, California, United States
- MedOne Clinical Research — Miami, Florida, United States
- Meridian International Research, Inc. — Miami Gardens, Florida, United States
- Combined Research — Orlando, Florida, United States
- Clinical Research Center of Florida — Pompano Beach, Florida, United States
- GCP Research — St. Petersburg, Florida, United States
- Cenexel Clinical Research — Atlanta, Georgia, United States
- CenExel Clinical Research — Decatur, Georgia, United States
- CenExel Clinical Research — Savannah, Georgia, United States
- Insight Hospital and Medical Center Chicago — Chicago, Illinois, United States
- Zucker Hillside Hospital — Glen Oaks, New York, United States
- Monroe Biomedical Research — Monroe, North Carolina, United States
- Maximos Ob/Gyn — League City, Texas, United States
- Pillar Clinical Researc — Richardson, Texas, United States
Full record on ClinicalTrials.gov
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