A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder

Inclusion Criteria:

• Outpatients aged 18 to 65 years (including both limits), either male or female;

• Meet the diagnostic criteria for depression in DSM-5 (the fifth edition of theDiagnostic and Statistical Manual of Mental Disorders), without psychotic symptoms;

• Have a total score of ≥ 22 on the 17-item Hamilton Depression Rating Scale (HAM-D17)at both screening and baseline visits;

• Have a Clinical Global Impression - Severity (CGI-S) score of ≥ 4 at both screeningand baseline visits;

• Voluntarily participate in this trial and sign the informed consent form, and beable to comply with the planned visits, treatment plan, laboratory tests and otherresearch procedures.

Exclusion Criteria:

• Allergic constitution (such as those allergic to two or more drugs or foods) orknown to be allergic to similar products like agomelatine;

• Have previously received adequate and full-course treatment with agomelatine butshowed no effect, or treatment-resistant depression (those who have used at leasttwo antidepressants in adequate and full-course treatment but still showed noeffect);

• HAM-D17 scale score reduction rate is ≥25% compared to the baseline period;

• High suicide risk; history of suicide attempts within one year before screening;suicidal or self-harming behavior during the screening period; score of ≥3 on item 3 (suicide item) of the HAM-D17 scale;

• Diagnosed with any disease other than depression according to DSM-5, includinganxiety disorders, neurodevelopmental disorders, schizophrenia spectrum and otherpsychotic disorders, bipolar and related disorders, obsessive-compulsive and relateddisorders, trauma and stress-related disorders, dissociative disorders, anorexia orbulimia nervosa, personality disorders, etc.;

• Depression secondary to other mental or physical diseases. Note: Otherinclusion/exclusion criteria may apply