Evaluating JS1-1-01 for treating 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

This study is testing a new medication called JS1-1-01 to see if it can help people with moderate to severe depression feel better compared to a placebo and an established antidepressant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tasly Pharmaceutical Group Co., Ltd (Industry-sponsored)
• Locations: 17 sites (Beijing, Beijing and 16 other locations)
• Trial ID: NCT06259526 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of a new medication, JS1-1-01, in patients suffering from moderate to severe depression. Participants will be randomly assigned to receive either the active drug, a placebo, or an established antidepressant, Duloxetine, to compare outcomes. The study will measure changes in depression severity using standardized scales over a specified period. The goal is to determine if JS1-1-01 can provide a viable treatment option for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of moderate to severe depression as per DSM-5 criteria.

Not a fit: Patients with severe drug allergies or those who have previously shown adverse reactions to similar medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with moderate to severe depression.

How similar studies have performed: While there have been studies on other antidepressants, the specific approach with JS1-1-01 is novel and has not been extensively tested in prior research.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 16 other locations

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

Study contacts

• Study coordinator: Gang Wang, Doctors

Conditions Depression