NCT07485595

A Study of the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression

A Phase 2/Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Placebo group	(2 of 50 mg JS1-1-01 placebo tablets+1 of 75 mg JS1-1-01 placebo tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.
DRUG	JS1-1-01 low-dose group	(2 of 50 mg JS1-1-01 placebo tablets+1 of 75 mg JS1-1-01 tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.
DRUG	JS1-1-01 high-dose group	(2 of 50 mg JS1-1-01 tablets+1 of 75 mg JS1-1-01 placebo tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-03-20
• Last updated: 2026-04-08

Locations

1 site across 1 country: China