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

NCT07485595 | Not Yet Recruiting Phase 2

• 1 other identifier: TSL-CM-JS1-1-01-Ⅱb/Ⅲ
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• The change in HAMD-17 total score from baseline

  8 weeks

• The effective rate of MADRS

  8 weeks

• The effective rate of HAMD-17

  8 weeks

• The response rate of MADRS

  8 weeks

• The response rate of HAMD-17

  8 weeks

Other Outcomes (3)

• The change in ISI total score from baseline

  8 weeks

• The change in DSST total score from baseline

  8 weeks

• The change in PDQ-D total score from baseline

  8 weeks

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Drug: Placebo group

JS1-1-01 low-dose group

EXPERIMENTAL

Drug: JS1-1-01 low-dose group

JS1-1-01 high-dose group

EXPERIMENTAL

Drug: JS1-1-01 high-dose group

Interventions

Placebo group DRUG

(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.

Also known as: JS1-1-01 placebo tablet

Placebo group

JS1-1-01 low-dose group DRUG

(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.

Also known as: JS1-1-01 tablet ; JS1-1-01 placebo tablet

JS1-1-01 low-dose group

JS1-1-01 high-dose group DRUG

(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.

Also known as: JS1-1-01 tablet ; JS1-1-01 placebo tablet

JS1-1-01 high-dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18 to 65 years old (including boundary values), both male and female;
• 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.
• Screening and baseline periods, the total score of the Montgomery Asperger Depression Rating Scale (MADRS) was ≥ 26 points;
• Screening and baseline periods, with a Clinical Global Impression Scale Disease Severity (CGI-S) score of ≥ 4 points;
• Voluntary participation in clinical trials, able to sign informed consent forms, and able to understand and comply with research procedures.

You may not qualify if:

• Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) ;
• 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;
• The patients of depression secondary to other mental or physical illnesses;
• Patients of depression with accompanying psychiatric symptoms;
• Significant suicidal attempt or behavior within the past year, with a score of ≥ 3 on the 10th item (suicidal ideation) of the MADRS scale;
• Individuals with a history of epileptic seizures (excluding convulsions caused by febrile seizures in children);
• 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;
• Systematically receiving antidepressant treatment within the first 2 weeks of randomization, or discontinuing antidepressant medication for less than 5 half-lives before randomization;
• 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;
• Accompanied by a history of malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
• During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period;
• A history of symptomatic orthostatic hypotension (i.e. orthostatic syncope) with clinical significance;
• 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;
• 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;
• Screening period, drug abuse screening positive individuals;

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

Gang Wang

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Depression

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)