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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259526
• Other study ID #: TSL-CM-JS1-1-01-?
• Status: Recruiting
• Phase: Phase 2
• Start date: December 26, 2023
• Est. completion date: April 26, 2025

Study information

• Verified date: February 2024
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: Gang Wang, Doctors
• Phone: 010-58303236
• Email: adgangwang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: April 26, 2025
• Est. primary completion date: April 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Placebo group
(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.
• JS1-1-01 low-dose group
(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.
• JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules
(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.
• JS1-1-01 high-dose group
(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.
• Active drug group
(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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change in HAMD-17 total score from baseline	There are a total of 17 projects in Hamilton Depression Scale-17(HAMD-17). Scores are distributed on a scale of 0 to 53. A score above 24 indicates severe depression, a score of 17 indicates moderate depression, and a score below 7 indicates no depressive symptoms.	8 weeks
Secondary	The effective rate of MADRS	The effective definition of MADRS is that the reduction rate of MADRS score relative to baseline is = 50%.	8 weeks
Secondary	The effective rate of HAMD-17	The effective definition of HAMD-17 is that the reduction rate of HAMD-17 score relative to baseline is = 50%.	8 weeks
Secondary	The response rate of MADRS	The response definition of MADRS is that the score = 12 points.	8 weeks
Secondary	The response rate of HAMD-17	The response definition of HAMD-17 is that the score = 7 points.	8 weeks
Secondary	The change in CGI-I and CGI-S total score from baseline	Perform the Clinical Global Impression Scale (CGI-S) score from Visit 1 to Visit 7, and perform the Clinical Global Impression Scale (CGI-I) score from Visit 3 to Visit 7.The highest score is 7 points, and the higher the score, the more severe the condition will be.	8 weeks
Secondary	The change in HAMA total score from baseline	There are a total of 14 projects in Hamilton Anxiety Scale(HAMA), each with a 5-point scoring system ranging from 0 to 4 points. A total score of less than 6 on the scale is considered normal, a score of 7-14 indicates possible anxiety, a score of 15-20 indicates certain anxiety, a score of 21-28 indicates obvious anxiety, and a total score of more than 28 indicates severe anxiety. The higher the score, the more severe the anxiety.	8 weeks
Secondary	The change in MADRS Single item score from baseline	The higher the score, the more severe the degree of depression.	8 weeks
Secondary	The change in HAMD-17 factor score from baseline	The higher the score, the more severe the degree of depression.	8 weeks
Secondary	The change in SHAPS total score from baseline	There are a total of 14 projects in Snaith-Hamilton Pleasure Scale(SHAPS), each with a 4-point scoring system ranging from 1 to 4 points. Scores are distributed between 14-56 points. The higher the score, the more severe the anhedonia.	8 weeks