Not Yet RecruitingPhase 2/3

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

China180 participantsStarted 2026-04-30

Plain-language 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

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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);
✕. 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;

The change in MADRS total score from baseline

Timeframe: 8 weeks

NCT IDNCT07485595

SponsorTasly Pharmaceutical Group Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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);
✕. 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;