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

NCT06259526 | Completed Phase 2

• 1 other identifier: TSL-CM-JS1-1-01-Ⅱ
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 17

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

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 (10)

• 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

Study Arms (5)

Placebo group

PLACEBO COMPARATOR

Drug: Placebo group

JS1-1-01 low-dose group

EXPERIMENTAL

Drug: JS1-1-01 low-dose group

JS1-1-01 medium dose group

EXPERIMENTAL

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

JS1-1-01 high-dose group

EXPERIMENTAL

Drug: JS1-1-01 high-dose group

Active drug group

ACTIVE COMPARATOR

Drug: Active drug group

Interventions

Placebo group 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.

Also known as: JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules

Placebo group

JS1-1-01 low-dose group 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.

Also known as: JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules

JS1-1-01 low-dose group

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

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

JS1-1-01 medium dose group

JS1-1-01 high-dose group 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.

Also known as: JS1-1-01 pills; Duloxetine hydrochloride placebo capsules

JS1-1-01 high-dose group

Active drug group 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.

Also known as: JS1-1-01 placebo pills; Duloxetine hydrochloride enteric coated capsule

Active drug 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:

• All of the following standards must be met:
• Age range from 18 to 65 years old (including boundary values), both male and female;
• 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);
• During the 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:

• Those who meet any of the following criteria cannot be included in this experiment:
• Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) or Duloxetine;
• 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;
• Those who have been ineffective in using Duloxetine in sufficient amounts during the previous treatment course;
• 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;
• During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period;
• 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;
• Individuals with severe unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, and other physical diseases or medical history;
• Accompanied by a history of malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
• 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;

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (17)

Capital Medical University Affiliated Anding Hospital

Beijing, Beijing Municipality, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Location

Chongqing 11th People's Hospital

Chongqing, Chongqing Municipality, China

Location

Chongqing Mental Health Center

Chongqing, Chongqing Municipality, China

Location

The Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Hebei Provincial Mental Health Center

Baoding, Hebei, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Daqing Third Hospital

Daqing, Heilongjiang, China

Location

Wuxi Mental Health Center

Wuxi, Jiangsu, China

Location

Zhenjiang Mental Health Center

Zhenjiang, Jiangsu, China

Location

Jiangxi Provincial Psychiatric Hospital

Nanchang, Jiangxi, China

Location

Jilin Provincial Neuropsychiatric Hospital

Siping, Jilin, China

Location

Shandong Provincial Mental Health Center

Jinan, Shandong, China

Location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

Location

Ürümqi Fourth People's Hospital

Ürümqi, Xinjiang, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Huzhou Third People's Hospital

Huzhou, Zhejiang, 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: February 6, 2024
• First Posted: February 14, 2024
• Study Start: December 26, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)