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UNKNOWNPHASE2

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

NCT05937867•Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female subjects aged 18 to 45 years (including cut-off)
•Based on the investigator's clinical evaluation, subjects met the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria for recurrent depressive disorder (MDD) or single episode MDD without psychotic symptoms, and the onset of this depression occurred between 28 weeks of gestation and 4 weeks postpartum
•≤12 months post partum
•Hamilton Depression Scale (HAM-D17) total score ≥26
•Subjects who are not taking antidepressants for a current episode, or who have taken an oral antidepressant (SSRIs or SNRIs limited, including citalopram, Escitalopram, paroxetine, sertraline, venlafaxine, norvenlafaxine, duloxetine, Minapram) for at least 30 days at a pre-screening stable dose (allowing for a reduction of the drug within 1 week prior to screening),Or who had used any antidepressant before screening but had stopped taking it for at least five drug half-lives
•Agree to discontinue the use of other new antidepressants, antipsychotics, mood stabilizers, and benzodiazepine sedatives and hypnotics during administration
•According to the investigators, the subjects were generally in good physical condition, and no clinically significant abnormalities were found in physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, etc.) during screening
•Urine beta-human chorionic gonadotropin (beta-hCG) negative
•Agree to abstain from sex or other effective contraceptive methods for 30 days from screening until the last dose, and no egg donation plan is planned during this period
•If you have stopped breastfeeding, you must agree to stop breastfeeding before the first dose, and at least 7 days after the last dose.Able to communicate well with researchers, willing and able to comply with the lifestyle restrictions specified in the protocol, and cooperate with the completion of the experiment
+1 more criteria

Exclusion Criteria

•Accompanied by psychotic symptoms
•In addition to depression, current history and previous history met the diagnostic criteria for other psychiatric disorders in the DSM-5 and were judged by the investigators to have potential implications for clinical studies
•Meet the diagnostic criteria for treatment-resistant depressive disorder
•Homicidal ideation/intent was present, or based on the Columbia Suicide Severity Assessment Scale (C-SSRS), the subject had a history of suicidal intent/self-harm behavior during the current depressive episode
•Atypical antipsychotics, mood stabilizers (e.g., olanzapine, risperidone, quetiapine, aripiprazole, iprazole, Ziprasidone, calilrazine, sodium valproate, lithium carbonate) were used during the current depressive episode.
•History of modified electrical tics (MECT), transcranial magnetic stimulation (TMS), or prior treatment with vagus nerve stimulation (VNS) or deep brain stimulation (DBS) within 1 month prior to screening
•Present or previous history of disease or dysfunction affecting clinical trials, including but not limited to nervous system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal musculoskeletal system, metabolic endocrine system, skin disease, blood system disease, immune disease and tumor, clinically significant chronic disease or poor disease control,The researchers assessed that they were not fit to participate in this study
•The presence of any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or that may pose a hazard to the subjects participating in the trial;Such as gastrointestinal surgery history (gastrectomy, gastrostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding history, etc
•Previous history of seizures (except convulsions caused by febrile convulsions in children)
•History of severe allergies
+9 more criteria

Key Dates

Start Date

August 31, 2023

Primary Completion Date

February 28, 2025

Completion Date

October 31, 2025

Last Updated

July 10, 2023

Enrollment

ESTIMATED participants

Conditions

Postpartum Depression

Interventions

HS-10353 Capsules 30 mg, Oral, QN for 14 days

DRUG

HS-10353 Capsules 50 mg, Oral, QN for 14 days

DRUG

HS-10353 Capsules matching placebo, 30mg, Oral, QN for 14 days.

DRUG

HS-10353 Capsules matching placebo, 50mg, Oral, QN for 14 days

DRUG

Contacts

Yun Chen

CONTACT

18652105250 cheny22@hspharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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