Clinical Trial of TJ0113 Capsules in the Treatment of Patients With Depressive Disorder

This study is a phase II, randomized, double-blind, multi-center, placebo-controlled, parallel-group clinical trial and 150 subjects with depressive disorder will be enrolled. Subjects will be randomly assigned in a 1:1 ratio to two cohorts (Cohort 1: 200 mg dose group; Cohort 2: 400 mg dose group). Within each cohort, subjects will be randomized in a 2:1 ratio to either the TJ0113 capsule group or the placebo group, with approximately 50 subjects receiving TJ0113 capsules and approximately 25 receiving placebo. Approximately 50 subjects will be enrolled in each of the TJ0113 capsule 200 mg group, TJ0113 capsule 400 mg group, and placebo group in this trial. Eligible subjects will be randomly assigned to receive continuous oral administration for 8 weeks, after which efficacy and safety will be evaluated, followed by an additional 1-week follow-up period after the end of treatment.

Inclusion Criteria: 1. Subjects who voluntarily participates in the trial and signs the informed consent form (ICF); 2. Male or female subjects, aged between 18 and 65 years (inclusive) at the time of signing ICF; 3. Subjects whose HAMD-17 score ≥18 during the screening and baseline periods; 4. Subjects who meet the diagnostic criteria for depressive disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), without psychotic symptoms; 5. Subjects whose Clinical Global Impressions-Severity (CGI-S) scores ≥4 during the screening and baseline periods; 6. Subjects who agree to discontinue the use of other antidepressants, anxiolytics, antipsychotics, mood stabilizers, benzodiazepine sedative-hypnotics, etc., except those specified in the study protocol during the treatment period; Subjects with reproductive potential (including spouses of male subjects) must have no plans for pregnancy or sperm donation from the screening period until 6 months after the last dose and must be willing to use at least one effective contraceptive method (such as abstinence, condoms, etc., as detailed in Section 5.3). Exclusion Criteria: 1. Presence of any medical condition that may interfere with the participation in the trial, including but not limited to the following: history of malignant tumors, history of epilepsy or complications, hemolytic anemia, pulmonary embolism, or respiratory depression; 2. Within 6 months prior to screening, occurrence of congestive heart failure classified as New York Heart Association (NYHA) Class III or higher, unstable angina, acute myocardial infarction, hemorrhagic stroke (stroke), or ischemic stroke (including transient ischemic attack); or undergoing percutaneous coronary intervention, coronary artery bypass grafting, cardiac valve repair/replacement; or presence of severe arrhythmia as determined by the investigator at screening; 3. A personal or family history of long QT syndrome, a family history of sudden death in first-degree relatives (parents, offspring, and siblings) before the age of 40; and/or a personal history of unexplained syncope within 1 year prior to screening; and/or QTcF \>450 ms (male) or QTcF \>470 ms (female) based on resting ECG results at screening; 4. Patients with uncontrolled hypertension at screening, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (checked prior to randomization); 5. Subjects with clinically significant hepatic impairment, defined as total bilirubin (TBIL) \>2× the upper limit of normal (ULN) or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2×ULN; 6. Subjects with clinically significant renal impairment (creatinine clearance \[Ccr\] \