About this trial
The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Placebo group
- JS1-1-01 low-dose group
- JS1-1-01 high-dose group