Trials / Recruiting

RecruitingNCT06270433

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 80 (estimated)

Sponsor: Jiangsu Province Nanjing Brain Hospital · 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 anhedonia in patients with major depression disorder compared to desvenlafaxine succinate 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 desvenlafaxine succinate 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

Anhedonia

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	Desvenlafaxine succinate sustained-release tablets	50 mg orally once daily dosing for 8 weeks

Timeline

Start date: 2024-02-19
Primary completion: 2024-12-31
Completion: 2024-12-31
First posted: 2024-02-21
Last updated: 2024-04-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06270433. Inclusion in this directory is not an endorsement.