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A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
Sponsor: TWi Biotechnology, Inc.
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2024-03-28
Completion Date
2025-10-06
Last Updated
2026-07-31
Healthy Volunteers
No
Conditions
Interventions
NORA520 Dose 1
Oral NORA520 tablets Dose 1 for 3 days
NORA520 Dose 2
Oral NORA520 tablets Dose 2 for 3 days
Placebo
Oral Placebo tablets for 3 days
Locations (18)
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