CompletedPhase 2

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

China267 participantsStarted 2023-12-26

Plain-language summary

The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 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 (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.

✕. 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;
✕. 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);

The change in MADRS total score from baseline

Timeframe: 8 weeks

NCT IDNCT06259526

SponsorTasly Pharmaceutical Group Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-23

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 (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.

✕. 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;
✕. 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);