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

Hansoh Pharma

Status and phase

Not yet enrolling

Phase 2

Conditions

Postpartum Depression

Treatments

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

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

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05937867

HS-10353-202

Details and patient eligibility

About

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).

Enrollment

96 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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
Subjects should fully understand the study content and process, as well as possible adverse reactions, and voluntarily sign an informed consent form (ICF).

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
A history of drug abuse or benzodiazepine dependence within the last 1 year
A history of alcohol abuse in the last 6 months (i.e. drinking more than 14 standard units per week, 1 unit =360ml beer or 45ml spirits with 40% alcohol or 150ml wine)
Participate in any clinical study within 30 days prior to screening
Take CYP3A4, CYP2C9, or CYP2C19 suppressants (e.g. Clarithromycin, itraconazole, ketoconazole, voriconazole, fluvoxamine, fluconazole, fluoxetine, ticlopidine) for 14 days prior to first dosing (or 5 half-lives, whichever is longer) and throughout the study period.Or grapefruit/grapefruit juice, grapefruit/grapefruit, Seville orange or products rich in such substances
CYP inducers such as rifampin, carbmazepine, Ritonavir, enzalutamide, efavirenan, nevirapine, phenytoin, phenobarbital, or St. John's Wort were taken within 14 days prior to first administration (or 5 half-lives, whichever is longer) and throughout the study period
12-lead electrocardiogram and other test indicators abnormal and clinically significant, such as: Friericia corrected QT interval (QTcF= QT/RR0.33), absolute value > 470ms
Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), syphilis seroresponse (TRUST) positive
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times upper limit of normal (ULN), serum creatinine (Cr) > 1.5 times ULN
Poor compliance or other problems, the researcher considered it inappropriate to participate in the study