NCT04364997

Study of Desvenlafaxine in Treating Major Depressive Disorder.

A Multi-center, Randomized, Double-blind, Double-simulation, Duloxetine Hydrochloride Enteric-coated Positive-control Phase III Study of Desvenlafaxine Succinate Sustained-Release in the Treatment of Major Depressive Disorder.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder.

Detailed description

This is a multicenter study to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder. A total of 400 subjects will be randomly allocated to experimental arm (desvenlafaxine succinate sustained-release tablet) and active comparator arm (duloxetine hydrochloride enteric-coated capsule) in a 1:1 ratio.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo	Desvenlafaxine Succinate Sustained-Release Tablet 50 mg+Duloxetine Hydrochloride Enteric-coated Capsule Placebo 60 mg orally once daily for 8 weeks.
DRUG	Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule	Desvenlafaxine Succinate Sustained-Release Tablet Placebo 50mg +Duloxetine Hydrochloride Enteric-coated Capsule 60mg orally once daily for 8 weeks,
DRUG	Duloxetine Hydrochloride Enteric-coated Capsule Placebo	Duloxetine Hydrochloride Enteric-coated Capsule Placebo 30 mg orally once daily for 1 week after 8-weeks treatment.
DRUG	Duloxetine Hydrochloride Enteric-coated Capsule	Duloxetine Hydrochloride Enteric-coated Capsule 30mg orally once daily for 1 week after 8-weeks treatment.

Timeline

• Start date: 2020-06-18
• Primary completion: 2021-09-22
• Completion: 2021-09-22
• First posted: 2020-04-28
• Last updated: 2021-12-03

Locations

1 site across 1 country: China