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

NCT05937867 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-07-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2025-02-28
Completion
2025-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937867 on ClinicalTrials.gov