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

PHASE2CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

December 26, 2023

Primary Completion Date

October 23, 2024

Study Completion Date

October 23, 2024

Conditions
Depression
Interventions
DRUG

Placebo group

(1 pill of 25 mg JS1-1-01 placebo pills +1 pill of 50 mg JS1-1-01 placebo pills+1 pill of duloxetine hydrochloride placebo capsule)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.

DRUG

JS1-1-01 low-dose group

(1 pill of 25 mg JS1-1-01 pills +1 pill of 50 mg JS1-1-01 placebo pills +1 pill of duloxetine hydrochloride placebo capsule)/time, 2 times/day, administered postprandial, for 8 consecutive weeks.

DRUG

JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules

(1 pill of 25 mg JS1-1-01 placebo pills+1 pill of 50 mg JS1-1-01 pills +1 pill of Duloxetine hydrochloride placebo capsule)/time, 2 times/day, administered postprandial, for 8 consecutive weeks.

DRUG

JS1-1-01 high-dose group

(1 pill of 25 mg JS1-1-01 pills +1 pill of 50 mg JS1-1-01 pills +1 pill of Duloxetine hydrochloride placebo capsule)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.

DRUG

Active drug group

(1 Duloxetine hydrochloride enteric coated capsule+1 pill of 25mg JS1-1-01 placebo pills+1 pill of 50mg JS1-1-01 placebo pills)/dose, 2 times per day, administered postprandial, for 8 consecutive weeks.

Trial Locations (17)

Unknown

Capital Medical University Affiliated Anding Hospital, Beijing

Peking University Sixth Hospital, Beijing

Chongqing 11th People's Hospital, Chongqing

Chongqing Mental Health Center, Chongqing

The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou

Hebei Provincial Mental Health Center, Baoding

The First Hospital of Hebei Medical University, Shijiazhuang

Daqing Third Hospital, Daqing

Wuxi Mental Health Center, Wuxi

Zhenjiang Mental Health Center, Zhenjiang

Jiangxi Provincial Psychiatric Hospital, Nanchang

Jilin Provincial Neuropsychiatric Hospital, Siping

Shandong Provincial Mental Health Center, Jinan

Tianjin Anding Hospital, Tianjin

Ürümqi Fourth People's Hospital, Ürümqi

The First Affiliated Hospital of Kunming Medical University, Kunming

Huzhou Third People's Hospital, Huzhou

All Listed Sponsors
lead

Tasly Pharmaceutical Group Co., Ltd

INDUSTRY

NCT06259526 - A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression | Biotech Hunter | Biotech Hunter