NCT03404466

To Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With MDD

A Multicenter,Randomized,Open-label,Parallel-group,and Adaptive Design Clinical Study to Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Zhejiang Huahai Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 score from baseline to week 6.

Detailed description

A total of 40 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments The subjects will accept the drug treatment twice daily orally for 6 weeks, During the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment ,43±2 days after treatment to evaluate the safety and efficacy of the drug.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Hypidone Hydrochloride tablets	Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks

Timeline

• Start date: 2018-02-24
• Primary completion: 2018-07-10
• Completion: 2018-07-17
• First posted: 2018-01-19
• Last updated: 2020-10-30

Locations

1 site across 1 country: China