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;