NCT07018245

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

A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-GroupClinical Trial to Evaluate the Safety and Efficacy of TJ0113 Capsules in Patients withDepressive Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hangzhou PhecdaMed Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	TJ0113	200 mg or 400 mg Capsule, Once Daily
DRUG	Placebo	Capsule, Once Daily

Timeline

• Start date: 2025-07-09
• Primary completion: 2026-05-25
• Completion: 2026-09-01
• First posted: 2025-06-12
• Last updated: 2026-01-28

Locations

1 site across 1 country: China