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Study identifier: NCT06285916 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Completed

A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression

Condition: Depression, Postpartum · Postpartum Depression · Post-partum Depression  ·  Sponsor: TWi Biotechnology, Inc.

PhasePhase 2
Planned participants93
Who can joinFemale, 18 Years to 45 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (18)

Pillar Clinical ResearchBentonville, Arkansas, United States
Advanced Research CenterAnaheim, California, United States
Alliance Research InstituteCanoga Park, California, United States
Cenexel Clinical ResearchSherman Oaks, California, United States
Cenexel Clinical ResearchTorrance, California, United States
MedOne Clinical ResearchMiami, Florida, United States
Meridian International Research, Inc.Miami Gardens, Florida, United States
Combined ResearchOrlando, Florida, United States
Clinical Research Center of FloridaPompano Beach, Florida, United States
GCP ResearchSt. Petersburg, Florida, United States
Cenexel Clinical ResearchAtlanta, Georgia, United States
CenExel Clinical ResearchDecatur, Georgia, United States

+ 6 more locations — full list on the registry record.

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