The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.
1. Subjects aged 18 and 65 years (inclusive), no gender limitation;
2. Subject has recurrent Major Depressive Disorder (MDD) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5, 5th Edition), single episode or recurrent episodes (classification code 296.2/296.3).The duration of the current depressive episode should be ≥3 months for first-episode patients and ≥1 month for relapsing patients;
3. Subjects with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 26 at screening and baseline. Subjects with Clinical Global Impression Scale Disease Severity CGI-S severity score ≥ 4 at screening and baseline. Score of first item (depressed mood) of the HAMD-17 scale ≥2 at the screening and baseline.
Be able to read and understand the study procedures and trial requirements, agree to abide by the restrictions of the trial and return to the site on time for evaluation, and sign the informed consent form prior to the trial.
1. Subjects with ≥ 25% reduction in MADRS score in the baseline period compared to the screening period;
A score of ≥4 on item 10 (Suicidal Ideation) of the MADRS scale;
Subjects who in the judgment of the investigator, are at significant risk for suicide (e.g., participant answered "yes" to question 4 (active suicidal ideation with intent to act but no specific plan) or question 5 (active suicidal ideation with a specific plan and intent) on the Screening C-SSRS and the most recent suicidal intent or suicidal plan occurred within the last six months);
Attempted suicide during the current depressive episode;
Parallel
Ammoxetine
DrugDrug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Ammoxetine and Sertraline.
Ammoxetine
DrugDrug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Sertraline.
Placebo
DrugDrug: Placebo placebo to Ammoxetine hydrochlorid and Sertraline.
Sertraline
DrugDrug: Sertraline positive control Drug: Placebo placebo to Ammoxetine hydrochlorid.
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement
Change from baseline in Hamilton Depression Scale (HAMD-17) at the end of treatment (week 8)
The HAMD-17 is a clinician-based assessment of depressive symptoms. The total score ranges from 0 to 53 with a higher score indicating more depression. A score of 0-9 is generally accepted to be within the normal range (or in clinical remission), while a score of greater than 17 indicates moderate to severe depression symptoms.
Change from baseline in The Clinical Global Impression Scale (CGI-S) scores at the end of treatment (week 8) at the end of treatment (week 8)
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
Clinical Global Impression Scale of Improvement (CGI-I) score at the end of treatment (week 8)
The CGI-I scale is a clinician-rated instrument that measures the improvement of the participant's symptoms of depression. It is a 7-point scale where a score of 1 indicates that the participant is "very much improved," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse."
The efficiency and remission of the MADRS score
Effectiveness is defined as ≥ 50% reduction in MADRS score relative to baseline after treatment. Remission is defined as MADRS score ≤ 10 after treatment.
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