Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06285916
PHASE2

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

Sponsor: TWi Biotechnology, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

NORA520 Dose 1

Oral NORA520 tablets Dose 1 for 3 days

DRUG

NORA520 Dose 2

Oral NORA520 tablets Dose 2 for 3 days

DRUG

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