NCT06828887

Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD

Multicenter,Randomized,Double-blind,Placebo,Parallel-controlled,Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of Major Depressive Disorder (MDD)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase II clinical trial aimed to determine the optimal dose of LV232 capsules for treating MDD, evaluate preliminary efficacy and safety, and provide a basis for Phase III trial design and dosing regimen determination.

Detailed description

This study adopts a multicenter, randomized, double-blind, placebo- and active-controlled parallel-group clinical trial design, aiming to evaluate the efficacy and safety of LV232 capsules ( 40 mg, and 60 mg, once daily) in patients with major depressive disorder (MDD). The trial plans to enroll 400 subjects, stratified by first episode or recurrence of the disease. Participants will be randomized in a 1:1:1:1 ratio into five groups: LV232 capsules 40 mg, 60 mg, placebo, and active control, with 100 subjects in each group. The treatment will be administered once daily for 8 consecutive weeks.

Conditions

• MDD

Interventions

Type	Name	Description
DRUG	LV232 40mg	LV232 capsules 2 capsules (20 mg/capsule) + LV232 capsule placebo 1 capsule + escitalopram oxalate tablet placebo 1 tablet
DRUG	LV232 60mg	LV232 capsules 3 capsules (20 mg/capsule) + escitalopram oxalate tablet placebo 1 tablet
DRUG	Escitalopram	LV232 capsule placebo 3 capsule + escitalopram oxalate tablet 1 tablet
DRUG	Placebo	LV232 capsule placebo 3 capsule + escitalopram oxalate tablet placebo 1 tablet

Timeline

• Start date: 2025-04-03
• Primary completion: 2026-09-01
• Completion: 2026-12-20
• First posted: 2025-02-17
• Last updated: 2025-04-24

Locations

1 site across 1 country: China