Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets

Exclusion Criteria

• •1. Subjects accord with other mental disorders diagnosed by DSM-5
• •2. Subjects who attempted to suicide, or who presently have a high risk of suicide, or with the tenth item (Suicidal ideation) of C-SSRS ≥ 3
• •3. Baseline total scores compared with the screening period, the reduction rate of MADRS ≥ 25%
• •4. Subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease
• •5. Subjects with clinically significant ECG abnormal (Male QTcF ≥ 450 msec, Female QTcF ≥ 470 msec)
• •6. Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication
• •7. Practicing 2 different treatment methods of antidepressants as recommended dose of full course (≥6 weeks)
• •8. Subjects who have had a Vagus Nerve Stimulation (VNS) device implanted, or who have received Modified Electric Convulsive Therapy (MECT) or Transcranial Magnetic Stimulation (TMS) within 3 months of Screening, or who received light treatment, laser treatment, acupuncture and other Chinese medicine treatment, biofeedback treatment within 2 weeks of Screening
• •9. Subjects with a history of true allergic response to more than 1 class of medications
• •10. Subjects who participated in a clinical trial within the last 30 days