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

NCT ID: NCT06259526

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-26
• Study Completion Date: 2024-10-23

Brief Summary

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

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DRUG

(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.

JS1-1-01 low-dose group

Group Type: EXPERIMENTAL

JS1-1-01 low-dose group

Intervention Type: DRUG

(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.

JS1-1-01 medium dose group

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

(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.

JS1-1-01 high-dose group

Group Type: EXPERIMENTAL

JS1-1-01 high-dose group

Intervention Type: DRUG

(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.

Active drug group

Group Type: ACTIVE_COMPARATOR

Active drug group

Intervention Type: DRUG

(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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules; JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules; JS1-1-01 pills; JS1-1-01 placebo pills; JS1-1-01 pills; Duloxetine hydrochloride placebo capsules; JS1-1-01 placebo pills; Duloxetine hydrochloride enteric coated capsule

Eligibility Criteria

Inclusion Criteria

• All of the following standards must be met:

1. Age range from 18 to 65 years old (including boundary values), both male and female;

2. Single or recurrent episodes (296.2/296.3) that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition);

3. During the screening and baseline periods, the total score of the Montgomery Asperger Depression Rating Scale (MADRS) was ≥ 26 points;

4. Screening and baseline periods, with a Clinical Global Impression Scale Disease Severity (CGI-S) score of ≥ 4 points;

5. Voluntary participation in clinical trials, able to sign informed consent forms, and able to understand and comply with research procedures.

Exclusion Criteria

• Those who meet any of the following criteria cannot be included in this experiment:

1. Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) or Duloxetine;

2. Those who have used at least two antidepressants in sufficient dosage and duration (treated according to the maximum dosage in the instructions for at least 4 weeks) in a single or current episode in the past but still have no effect;

3. Those who have been ineffective in using Duloxetine in sufficient amounts during the previous treatment course;

4. The patients of depression secondary to other mental or physical illnesses;

5. Patients of depression with accompanying psychiatric symptoms;

6. Significant suicidal attempt or behavior within the past year, with a score of ≥ 3 on the 10th item (suicidal ideation) of the MADRS scale;

7. During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period;

8. Individuals with a history of epileptic seizures (excluding convulsions caused by febrile seizures in children);

9. Individuals who have received depression related systemic physical therapy within 3 months prior to their first administration: modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), phototherapy, or systemic psychotherapy;

10. Systematically receiving antidepressant treatment within the first 2 weeks of randomization, or discontinuing antidepressant medication for less than 5 half-lives before randomization;

11. Individuals with severe unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, and other physical diseases or medical history;

12. Accompanied by a history of malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);

13. Screening or baseline electrocardiogram abnormalities that have clinical significance and are deemed unsuitable for inclusion by investigators, such as male QTcF ≥ 450 ms, female QTcF ≥ 470 ms, or having a history of long QT syndrome;

14. A history of symptomatic orthostatic hypotension (i.e. orthostatic syncope) with clinical significance;

15. During the screening or baseline period, TBIL is above 2 times the upper limit of normal value, and ALT or AST is above 2 times the upper limit of normal value; Cr is higher than 1.2 times the upper limit of normal value;

16. Thyroid dysfunction (TSH above 1.2 times the upper limit of normal value or below 0.8 times the lower limit of normal value) or the presence of hyperthyroidism or hypothyroidism determined by the investigators;

17. Individuals with a history of elevated intraocular pressure or narrow angle glaucoma;

18. Screening period, drug abuse screening positive individuals;

19. A history of alcohol dependence within one year prior to screening;

20. Pregnant and lactating women, male or female subjects who have a family planning or are unable to take effective contraceptive measures within 30 days after signing the informed consent form and ending the trial;

21. Screening for individuals who have participated in clinical trials and taken investigational drugs within the first 30 days;

22. The investigators believe that the subjects have poor compliance or there are other clinical, social, or family factors that are not suitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tasly Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Capital Medical University Affiliated Anding Hospital

Beijing, Beijing Municipality, China

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Chongqing 11th People's Hospital

Chongqing, Chongqing Municipality, China

Chongqing Mental Health Center

Chongqing, Chongqing Municipality, China

The Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Hebei Provincial Mental Health Center

Baoding, Hebei, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Daqing Third Hospital

Daqing, Heilongjiang, China

Wuxi Mental Health Center

Wuxi, Jiangsu, China

Zhenjiang Mental Health Center

Zhenjiang, Jiangsu, China

Jiangxi Provincial Psychiatric Hospital

Nanchang, Jiangxi, China

Jilin Provincial Neuropsychiatric Hospital

Siping, Jilin, China

Shandong Provincial Mental Health Center

Jinan, Shandong, China

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

Ürümqi Fourth People's Hospital

Ürümqi, Xinjiang, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Huzhou Third People's Hospital

Huzhou, Zhejiang, China

Countries

China

Other Identifiers

TSL-CM-JS1-1-01-Ⅱ

Identifier Type: -

Identifier Source: org_study_id