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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Drug: Placebo group; Drug: JS1-1-01 low-dose group; Drug: JS1-1-01 high-dose group

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Gang Wang

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age range from 18 to 65 years old (including boundary values), both male and female;
2. Single or recurrent episodes that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition);For patients with a single episode, the duration of this depressive episode must be ≥90 days.
3. 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:

1. Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) ;
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. The patients of depression secondary to other mental or physical illnesses;
4. Patients of depression with accompanying psychiatric symptoms;
5. Significant suicidal attempt or behavior within the past year, with a score of ≥ 3 on the 10th item (suicidal ideation) of the MADRS scale;
6. Individuals with a history of epileptic seizures (excluding convulsions caused by febrile seizures in children);
7. 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;
8. Systematically receiving antidepressant treatment within the first 2 weeks of randomization, or discontinuing antidepressant medication for less than 5 half-lives before randomization;
9. Those with severe unstable cardiovascular and cerebrovascular diseases, respiratory system diseases, gastrointestinal diseases, liver diseases, kidney diseases, blood diseases, endocrine diseases, or a history of such physical diseases;
10. Accompanied by a history of malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
11. 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;
12. During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period;
13. A history of symptomatic orthostatic hypotension (i.e. orthostatic syncope) with clinical significance;
14. 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;
15. 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; Individuals with a history of elevated intraocular pressure or narrow angle glaucoma;
16. Screening period, drug abuse screening positive individuals;
17. A history of alcohol dependence within one year prior to screening(Drinking alcohol for more than 5 years, equivalent ethanol intake, daily alcohol consumption: men >40 g/d, women >20 g/d; drinking ≤5 years, equivalent ethanol intake, history of heavy drinking (>80 g/d) within 2 weeks);
18. 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;
19. Screening for individuals who have participated in clinical trials and taken investigational drugs within the first 30 days;
20. 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	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.; Other Names: JS1-1-01 placebo tablet
Experimental: JS1-1-01 low-dose group	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.; Other Names: JS1-1-01 tablet ; JS1-1-01 placebo tablet
Experimental: JS1-1-01 high-dose group	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.; Other Names: JS1-1-01 tablet ; JS1-1-01 placebo tablet

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 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 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 response rate of HAMD-17	he response definition of HAMD-17 is that the score ≤ 7 points.	8 weeks
The change in CGI-S total score from baseline	Perform the Clinical Global Impression Scale (CGI-S) score from Visit 1 to Visit 7,The highest score is 7 points, and the higher the score, the more severe the condition will be.	8 weeks
Proportion of participants with a CGI-S score of 1/2	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
Proportion of CGI-I Scores on the Clinical Global Impression Scale	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 MADRS Single item score from baseline	Each single item has a 7-point scoring system ranging from 0 to 6 points. The higher the score, the more severe the degree of depression.	8 weeks
The change in HAMD-17 factor score from baseline	Items scored 0-4 (5-point scale, 8 items) Depressed mood, feelings of guilt, suicide, work and interests, retardation, agitation, psychic anxiety, somatic anxiety; Items scored 0-2 (3-point scale, 9 items) Difficulty falling asleep, insomnia during sleep, early awakening, gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, weight loss, insight. The higher the score, the more severe the degree of depression.	8 weeks
The change in HAMA total score from baseline	There are a total of 14 projects in Hamilton Scale（HAMA）.The total score ranges from a minimum of 0 to a maximum of 56. The higher the score, the more severe the anxiety.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in ISI total score from baseline	There are a total of 7 projects in Insomnia Severity Index（ISI） . The total score ranges from a minimum of 0 to a maximum of 28. The higher the score, the more severe the degree of insomnia.	8 weeks
The change in DSST total score from baseline	Participants are required to match symbols with numbers according to the coding key as many as possible within 90 seconds. One point is awarded for each correct matching item; the first 10 sample items are unscored and not timed. The total score ranges from a minimum of 0 to a maximum of 90. Higher scores indicate better cognitive processing speed and represent a superior outcome. The lower the score, the worse of the cognitive function.	8 weeks
The change in PDQ-D total score from baseline	The total score ranges from a minimum of 0 to a maximum of 80. The higher the score, the worse of the cognitive function.	8 weeks

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

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-Ⅱb/Ⅲ

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