DepressionPhase 2NCT06259526
A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression
A Phase 2 study testing JS1-1-01 low-dose group, JS1-1-01 high-dose group and Active drug group in people with Depression, run by Tasly Pharmaceutical Group Co., Ltd at 17 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- JS1-1-01 low-dose group, JS1-1-01 high-dose group and Active drug group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 17 sitesChina
- Study dates
- 26 Dec 2023to 23 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 23Show fewer
- 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);
- 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;
- 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;
- 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;
- Individuals with a history of elevated intraocular pressure or narrow angle glaucoma;
- Screening period, drug abuse screening positive individuals;
- A history of alcohol dependence within one year prior to screening;
- 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;
- Screening for individuals who have participated in clinical trials and taken investigational drugs within the first 30 days;
- The investigators believe that the subjects have poor compliance or there are other clinical, social, or family factors that are not suitable for enrollment.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Hebei Provincial Mental Health Center
Baoding, Hebei
Capital Medical University Affiliated Anding Hospital
Beijing, Beijing Municipality
Peking University Sixth Hospital
Beijing, Beijing Municipality
Chongqing 11th People's Hospital
Chongqing, Chongqing Municipality
Chongqing Mental Health Center
Chongqing, Chongqing Municipality
Daqing Third Hospital
Daqing, Heilongjiang
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Huzhou Third People's Hospital
Huzhou, Zhejiang
Shandong Provincial Mental Health Center
Jinan, Shandong
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Jiangxi Provincial Psychiatric Hospital
Nanchang, Jiangxi
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Jilin Provincial Neuropsychiatric Hospital
Siping, Jilin
Tianjin Anding Hospital
Tianjin, Tianjin Municipality
Ürümqi Fourth People's Hospital
Ürümqi, Xinjiang
Wuxi Mental Health Center
Wuxi, Jiangsu
Zhenjiang Mental Health Center
Zhenjiang, Jiangsu
About this study
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
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
- Being tested
- Placebo 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
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo groupDrug
Also called 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 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 groupDrug
Also called JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules
(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 capsulesDrug
Also called JS1-1-01 pills; JS1-1-01 placebo pills
(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 groupDrug
Also called JS1-1-01 pills; Duloxetine hydrochloride placebo capsules
(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 groupDrug
Also called JS1-1-01 placebo pills; Duloxetine hydrochloride enteric coated capsule
(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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo group |
| JS1-1-01 low-dose group | Experimental | Not described Receives: Drug: JS1-1-01 low-dose group |
| JS1-1-01 medium dose group | Experimental | Not described Receives: Drug: JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules |
| JS1-1-01 high-dose group | Experimental | Not described Receives: Drug: JS1-1-01 high-dose group |
| Active drug group | Active comparator | Not described Receives: Drug: Active drug group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (10)
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.
Measured: 8 weeks
The effective rate of MADRS
The effective definition of MADRS is that the reduction rate of MADRS score relative to baseline is ≥ 50%.
Measured: 8 weeks
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%.
Measured: 8 weeks
The response rate of MADRS
The response definition of MADRS is that the score ≤ 12 points.
Measured: 8 weeks
The response rate of HAMD-17
The response definition of HAMD-17 is that the score ≤ 7 points.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
The change in MADRS Single item score from baseline
The higher the score, the more severe the degree of depression.
Measured: 8 weeks
The change in HAMD-17 factor score from baseline
The higher the score, the more severe the degree of depression.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start26 Dec 2023
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259526
- Sponsor's protocol ID
- TSL-CM-JS1-1-01-Ⅱ
- Status last verified
- Nov 2025
- First submitted
- 6 Feb 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06259526
- Acronym / sponsor ID
- TSL-CM-JS1-1-01-Ⅱ
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All of the following standards must be met:
Key exclusion criteria (23 listed)
- Those who meet any of the following criteria cannot be included in this experiment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo groupAlso: 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 placebo pills+1 pill of duloxetine hydrochloride placebo capsule)/time, 2 times per day, administered postprandial, for 8 consecutive weeks. | Drug | Placebo group |
| JS1-1-01 low-dose groupAlso: JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsules(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. | Drug | JS1-1-01 low-dose group |
| JS1-1-01 pills; JS1-1-01 placebo pills; Duloxetine hydrochloride placebo capsulesAlso: JS1-1-01 pills; JS1-1-01 placebo pills(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. | Drug | JS1-1-01 medium dose group |
| JS1-1-01 high-dose groupAlso: JS1-1-01 pills; Duloxetine hydrochloride placebo capsules(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. | Drug | JS1-1-01 high-dose group |
| Active drug groupAlso: JS1-1-01 placebo pills; Duloxetine hydrochloride enteric coated capsule(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. | Drug | Active drug group |
Primary outcome
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.
10 secondary outcomes
The change in HAMD-17 total score from baseline
Time frame: 8 weeks
The effective rate of MADRS
Time frame: 8 weeks
The effective rate of HAMD-17
Time frame: 8 weeks
The response rate of MADRS
Time frame: 8 weeks
The response rate of HAMD-17
Time frame: 8 weeks
The change in CGI-I and CGI-S total score from baseline
Time frame: 8 weeks
The change in HAMA total score from baseline
Time frame: 8 weeks
The change in MADRS Single item score from baseline
Time frame: 8 weeks
The change in HAMD-17 factor score from baseline
Time frame: 8 weeks
The change in SHAPS total score from baseline
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS1-1-01 low-dose group, JS1-1-01 high-dose group and Active drug group in people with Depression, run by Tasly Pharmaceutical Group Co., Ltd at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in MADRS total score from baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.