NCT06285916

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: DuKang Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression, Postpartum
• Postpartum Depression
• Post-partum Depression
• Postnatal Depression
• Post-Natal Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-09-11
• Completion: 2025-10-06
• First posted: 2024-02-29
• Last updated: 2025-11-20

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study