DepressionPhase 2/3NCT07485595

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

A Phase 2/3 study testing JS1-1-01 low-dose group and JS1-1-01 high-dose group in people with Depression, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 Tablet 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 and JS1-1-01 high-dose group
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteChina
Study dates: 30 Apr 2026to 31 Dec 2026
Phase: Phase 2/3
Are there results?: Not yet: the study is under way

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

Age range from 18 to 65 years old (including boundary values), both male and female;
Single or recurrent episodes that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition);For patients with a single episode, the duration of this depressive episode must be ≥90 days.
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

Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) ;
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;
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;
Individuals with a history of epileptic seizures (excluding convulsions caused by febrile seizures in children);

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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;
Those with severe unstable cardiovascular and cerebrovascular diseases, respiratory system diseases, gastrointestinal diseases, liver diseases, kidney diseases, blood diseases, endocrine diseases, or a history of such physical diseases;
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;
During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period;
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(Drinking alcohol for more than 5 years, equivalent ethanol intake, daily alcohol consumption: men >40 g/d, women >20 g/d; drinking ≤5 years, equivalent ethanol intake, history of heavy drinking (>80 g/d) within 2 weeks);
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

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Gang Wang
Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase 2/Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression

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

Conditions: Depression
Being tested: Placebo group, JS1-1-01 low-dose group, JS1-1-01 high-dose 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 tablet
(2 of 50 mg JS1-1-01 placebo tablets+1 of 75 mg JS1-1-01 placebo tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.
JS1-1-01 low-dose groupDrug
Also called JS1-1-01 tablet ; JS1-1-01 placebo tablet
(2 of 50 mg JS1-1-01 placebo tablets+1 of 75 mg JS1-1-01 tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.
JS1-1-01 high-dose groupDrug
Also called JS1-1-01 tablet ; JS1-1-01 placebo tablet
(2 of 50 mg JS1-1-01 tablets+1 of 75 mg JS1-1-01 placebo tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.

Study groups in NCT07485595
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 high-dose group	Experimental	Not described Receives: Drug: JS1-1-01 high-dose 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 (11)

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
he response definition of HAMD-17 is that the score ≤ 7 points.
Measured: 8 weeks
The change in MADRS Single item score from baseline
Each single item has 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
The change in HAMD-17 factor score from baseline
1. Items scored 0-4 (5-point scale, 8 items) Depressed mood, feelings of guilt, suicide, work and interests, retardation, agitation, psychic anxiety, somatic anxiety
2. Items scored 0-2 (3-point scale, 9 items) Difficulty falling asleep, insomnia during sleep, early awakening, gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, weight loss, insight. The higher the score, the more severe the degree of depression.
Measured: 8 weeks
The change in CGI-S total score from baseline
Perform the Clinical Global Impression Scale (CGI-S) score from Visit 1 to Visit 7,The highest score is 7 points, and the higher the score, the more severe the condition will be.
Measured: 8 weeks
Proportion of participants with a CGI-S score of 1/2
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
Proportion of CGI-I Scores on the Clinical Global Impression Scale
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 Scale（HAMA）.The total score ranges from a minimum of 0 to a maximum of 56. The higher the score, the more severe the anxiety.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202631 Dec 2026

First posted20 Mar 2026
Study start30 Apr 2026 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07485595
Sponsor's protocol ID: TSL-CM-JS1-1-01-Ⅱb/Ⅲ
Status last verified: Mar 2026
First submitted: 16 Mar 2026
Last updated: 8 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2/Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression
ClinicalTrials.gov ID: NCT07485595
Acronym / sponsor ID: TSL-CM-JS1-1-01-Ⅱb/Ⅲ
Conditions: Depression
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 180 participants (estimated)
Lead sponsor: Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
Study start: 30 Apr 2026 (estimated)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 20 Mar 2026 (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 Tablet 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: 3

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 high-dose group	Experimental	Drug: JS1-1-01 high-dose group

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age range from 18 to 65 years old (including boundary values), both male and female;
Single or recurrent episodes that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition);For patients with a single episode, the duration of this depressive episode must be ≥90 days.
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.

Key exclusion criteria (20 listed)

Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) ;
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;
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;

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 tablet(2 of 50 mg JS1-1-01 placebo tablets+1 of 75 mg JS1-1-01 placebo tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.	Drug	Placebo group
JS1-1-01 low-dose groupAlso: JS1-1-01 tablet ; JS1-1-01 placebo tablet(2 of 50 mg JS1-1-01 placebo tablets+1 of 75 mg JS1-1-01 tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.	Drug	JS1-1-01 low-dose group
JS1-1-01 high-dose groupAlso: JS1-1-01 tablet ; JS1-1-01 placebo tablet(2 of 50 mg JS1-1-01 tablets+1 of 75 mg JS1-1-01 placebo tablets)/time, 2 times per day, administered postprandial, for 8 consecutive weeks.	Drug	JS1-1-01 high-dose 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.

11 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 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 CGI-S total score from baseline
Time frame: 8 weeks
Proportion of participants with a CGI-S score of 1/2
Time frame: 8 weeks
Proportion of CGI-I Scores on the Clinical Global Impression Scale
Time frame: 8 weeks
The change in HAMA total score from baseline
Time frame: 8 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing JS1-1-01 low-dose group and JS1-1-01 high-dose group in people with Depression, run by Tasly Pharmaceutical Group Co., Ltd at 1 site 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 5 inclusion and 20 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: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

On the ClinicalTrials.gov record for NCT07485595.

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 8 Apr 2026.