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 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;
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;
Parallel
Placebo group
Drug(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 group
Drug(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 group
Drug(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.
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.
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.
The effective rate of MADRS
The effective definition of MADRS is that the reduction rate of MADRS score relative to baseline is ≥ 50%
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%.
The response rate of MADRS
The response definition of MADRS is that the score ≤ 12 points.
The change in ISI total score from baseline
There are a total of 7 projects in Insomnia Severity Index（ISI） . The total score ranges from a minimum of 0 to a maximum of 28. The higher the score, the more severe the degree of insomnia.
The change in DSST total score from baseline
Participants are required to match symbols with numbers according to the coding key as many as possible within 90 seconds. One point is awarded for each correct matching item; the first 10 sample items are unscored and not timed. The total score ranges from a minimum of 0 to a maximum of 90. Higher scores indicate better cognitive processing speed and represent a superior outcome. The lower the score, the worse of the cognitive function.
The change in PDQ-D total score from baseline
The total score ranges from a minimum of 0 to a maximum of 80. The higher the score, the worse of the cognitive function.
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