Clinical trial NCT06259526: A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The change in MADRS total score from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: The change in HAMD-17 total score from baseline
timeFrame: 8 weeks
measure: The effective rate of MADRS
timeFrame: 8 weeks
measure: The effective rate of HAMD-17
timeFrame: 8 weeks
measure: The response rate of MADRS
timeFrame: 8 weeks
measure: The response rate of HAMD-17
timeFrame: 8 weeks
measure: The change in CGI-I and CGI-S total score from baseline
timeFrame: 8 weeks
measure: The change in HAMA total score from baseline
timeFrame: 8 weeks
measure: The change in MADRS Single item score from baseline
timeFrame: 8 weeks
measure: The change in HAMD-17 factor score from baseline
timeFrame: 8 weeks
measure: The change in SHAPS total score from baseline
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Affiliated Anding Hospital
state: Beijing
city: Peking
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing 11th People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Mental Health Center
state: Chongqing
city: Guangzhou
country: China
facility: The Affiliated Brain Hospital of Guangzhou Medical University
state: Guangdong
city: Baoding
country: China
facility: Hebei Provincial Mental Health Center
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Daqing
country: China
facility: Daqing Third Hospital
state: Heilongjiang
city: Wuxi
country: China
facility: Wuxi Mental Health Center
state: Jiangsu
city: Zhenjiang
country: China
facility: Zhenjiang Mental Health Center
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Psychiatric Hospital
state: Jiangxi
city: Siping
country: China
facility: Jilin Provincial Neuropsychiatric Hospital
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Mental Health Center
state: Shandong
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
city: Ürümqi
country: China
facility: Ürümqi Fourth People's Hospital
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Huzhou
country: China
facility: Huzhou Third People's Hospital
state: Zhejiang
Study officials:
References: