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

Tasly Pharmaceutical Group Co., Ltd17 sites in 1 country267 target enrollmentDecember 26, 2023

InterventionsPlacebo group JS1-1-01 low-dose group JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules JS1-1-01 high-dose group Active drug group

DrugsPlacebo group JS1-1-01 low-dose group JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules JS1-1-01 high-dose group Active drug group

Overview

Phase: Phase 2
Intervention: Placebo group
Conditions: Depression
Sponsor: Tasly Pharmaceutical Group Co., Ltd
Enrollment: 267
Locations: 17
Primary Endpoint: The change in MADRS total score from baseline
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 26, 2023

End Date

October 23, 2024

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;

Arms & Interventions

Placebo group

Intervention: Placebo group

JS1-1-01 low-dose group

Intervention: JS1-1-01 low-dose group

JS1-1-01 medium dose group

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

JS1-1-01 high-dose group

Intervention: JS1-1-01 high-dose group

Active drug group

Intervention: Active drug group

Outcomes

Primary Outcomes

The change in MADRS total score from baseline

Time Frame: 8 weeks

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.