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

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

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

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Placebo group; Drug: JS1-1-01 low-dose group; Drug: JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules; Drug: JS1-1-01 high-dose group; Drug: Active drug group

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Capital Medical University Affiliated Anding Hospital
    • Beijing, Beijing Municipality, China
      • Peking University Sixth Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Chongqing 11th People's Hospital
    • Chongqing, Chongqing Municipality, China
      • Chongqing Mental Health Center
  • Guangdong
    • Guangzhou, Guangdong, China
      • The Affiliated Brain Hospital of Guangzhou Medical University
  • Hebei
    • Baoding, Hebei, China
      • Hebei Provincial Mental Health Center
    • Shijiazhuang, Hebei, China
      • The First Hospital of Hebei Medical University
  • Heilongjiang
    • Daqing, Heilongjiang, China
      • Daqing Third Hospital
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Wuxi mental health center
    • Zhenjiang, Jiangsu, China
      • Zhenjiang Mental Health Center
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Provincial Psychiatric Hospital
  • Jilin
    • Siping, Jilin, China
      • Jilin Provincial Neuropsychiatric Hospital
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Mental Health Center
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Anding Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Urumqi Fourth People's Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Huzhou, Zhejiang, China
      • Huzhou third people's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	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.; Other Names: JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules
Experimental: JS1-1-01 low-dose group	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.; Other Names: JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules
Experimental: JS1-1-01 medium dose group	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.; Other Names: JS1-1-01 pills; JS1-1-01 placebo pills
Experimental: JS1-1-01 high-dose group	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.; Other Names: JS1-1-01 pills; Duloxetine hydrochloride placebo capsules
Active Comparator: Active drug group	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.; Other Names: JS1-1-01 placebo pills; Duloxetine hydrochloride enteric coated capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in MADRS total score from baseline	There are a total of 10 projects in Montgomery-Asberg Depression Rating Scale（MADRS）, each with a 7-point scoring system ranging from 0 to 6 points. The higher the score, the more severe the degree of depression.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in HAMD-17 total score from baseline	There are a total of 17 projects in Hamilton Depression Scale-17（HAMD-17）. Scores are distributed on a scale of 0 to 53. A score above 24 indicates severe depression, a score of 17 indicates moderate depression, and a score below 7 indicates no depressive symptoms.	8 weeks
The effective rate of MADRS	The effective definition of MADRS is that the reduction rate of MADRS score relative to baseline is ≥ 50%.	8 weeks
The effective rate of HAMD-17	The effective definition of HAMD-17 is that the reduction rate of HAMD-17 score relative to baseline is ≥ 50%.	8 weeks
The response rate of MADRS	The response definition of MADRS is that the score ≤ 12 points.	8 weeks
The response rate of HAMD-17	The response definition of HAMD-17 is that the score ≤ 7 points.	8 weeks
The change in CGI-I and CGI-S total score from baseline	Perform the Clinical Global Impression Scale (CGI-S) score from Visit 1 to Visit 7, and perform the Clinical Global Impression Scale (CGI-I) score from Visit 3 to Visit 7.The highest score is 7 points, and the higher the score, the more severe the condition will be.	8 weeks
The change in HAMA total score from baseline	There are a total of 14 projects in Hamilton Anxiety Scale（HAMA）, each with a 5-point scoring system ranging from 0 to 4 points. A total score of less than 6 on the scale is considered normal, a score of 7-14 indicates possible anxiety, a score of 15-20 indicates certain anxiety, a score of 21-28 indicates obvious anxiety, and a total score of more than 28 indicates severe anxiety. The higher the score, the more severe the anxiety.	8 weeks
The change in MADRS Single item score from baseline	The higher the score, the more severe the degree of depression.	8 weeks
The change in HAMD-17 factor score from baseline	The higher the score, the more severe the degree of depression.	8 weeks
The change in SHAPS total score from baseline	There are a total of 14 projects in Snaith-Hamilton Pleasure Scale（SHAPS）, each with a 4-point scoring system ranging from 1 to 4 points. Scores are distributed between 14-56 points. The higher the score, the more severe the anhedonia.	8 weeks

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2023
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: TSL-CM-JS1-1-01-Ⅱ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No