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

• Status: Completed
• Trial end date: 2019-12-23
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride tablets in treatment of patients with major depressive disorder (MDD) by evaluating the change of MADRS total scores from baseline to week 6.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Synergy Pharmaceutical Sciences Co., Ltd.; Zhejiang Huahai Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

1. Outpatient or Inpatient, 18-65 years old, male or female

2. Current major depressive disorder diagnosed by DSM-5, single episode(296.21, 296.22, 296.23), or recurrent episode(296.31, 296.32, 296.33)

3. Montgomery-Åsberg Depression Rating Scale (MADRS) total scores in both Screening and Baseline ≥ 26

4. The first item of MADRS in both Screening and Baseline ≥ 3

5. CGI-S in both Screening and Baseline ≥ 4

6. Able to provide written informed consent forms

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