NCT05937867

A Phase II Study of HS-10353 in Participants With Postpartum Depression

A Randomized, Double-blinded, Placebo-controlled，Phase II Clinical Study to Evaluate the Efficacy and Safety of HS-10353 in Participants With Postpartum Depression

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine if treatment with HS-10353 reduces depressive symptoms in participants with postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score at Day 15. And the secondary purpose of this study is to evaluate the safety and tolerability of HS-10353 compared to placebo as assessed by the incidence of adverse events, clinical laboratory evaluations, electrocardiogram (ECG) parameters, the Columbia Suicide Severity Rating Scale (C-SSRS), and the 20-item Physician Withdrawal Checklist (PWC-20).

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
DRUG	HS-10353 Capsules 30 mg, Oral, QN for 14 days	HS-10353 Capsules 30 mg
DRUG	HS-10353 Capsules 50 mg, Oral, QN for 14 days	HS-10353 Capsules 50 mg
DRUG	HS-10353 Capsules matching placebo, 30mg, Oral, QN for 14 days.	Placebo
DRUG	HS-10353 Capsules matching placebo, 50mg, Oral, QN for 14 days	Placebo

Timeline

• Start date: 2023-08-31
• Primary completion: 2025-02-28
• Completion: 2025-10-31
• First posted: 2023-07-10
• Last updated: 2023-07-10