Clinical Trial of TJ0113 Capsules in the Treatment of Patients With Depressive Disorder
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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 month