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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739632 on ClinicalTrials.gov