Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets
NCT03739632 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2020-10-30
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.
Conditions
Interventions
- DRUG
-
Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
- OTHER
-
Placebo
Placebo tablets will be given orally, twice daily, for 6 weeks
Sponsors & Collaborators
-
Zhejiang Huahai Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Huafang Li, PhD · Shanghai Mental Health Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-30
- Primary Completion
- 2019-12-18
- Completion
- 2019-12-23
Countries
- China
Study Locations
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