NCT06278038

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder: a Multicentre, Open-label, Parallel-group, Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use.

Detailed description

The study included 80 patients with major depression disorder (aged 18 to 65 years) who meet the diagnostic criteria for depression in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Eligible patients were randomly assigned (1:1) to 8-week treatment with toludesvenlafaxine hydrochloride sustained-release tablets (n=40) or venlafaxine hydrochloride sustained-release tablets (n=40), followed up at period of enrollment as baseline and at the end of 2th, 4th and 8th weeks. Adverse events were recorded.

Conditions

• Major Depression Disorder

Interventions

Type	Name	Description
DRUG	Toludesvenlafaxine hydrochloride sustained-release tablets	80 mg or 120 mg or 160 mg orally once daily dosing for 8 weeks
DRUG	Venlafaxine hydrochloride sustained-release tablets	75 mg or 150 mg or 225 mg orally once daily dosing for 8 weeks

Timeline

• Start date: 2024-02-22
• Primary completion: 2024-11-10
• Completion: 2024-11-19
• First posted: 2024-02-26
• Last updated: 2025-04-01

Locations

1 site across 1 country: China