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

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