RecruitingPhase 2NCT06828887

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)


Sponsor

Vigonvita Life Sciences

Enrollment

400 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is finding the right dose of an experimental oral medication called LV232 for treating major depressive disorder (MDD) — persistent, debilitating depression that interferes significantly with daily life. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with major depressive disorder based on the DSM-5 criteria (a standard psychiatric diagnostic system) - You are currently experiencing a depressive episode that is moderate to severe - You are in generally good physical health **You may NOT be eligible if...** - You have a history of other psychiatric conditions such as bipolar disorder, schizophrenia, or psychosis - You are at significant risk of suicide - You are currently taking certain medications that could interact with LV232 - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLV232 40mg

LV232 capsules 2 capsules (20 mg/capsule) + LV232 capsule placebo 1 capsule + escitalopram oxalate tablet placebo 1 tablet

DRUGLV232 60mg

LV232 capsules 3 capsules (20 mg/capsule) + escitalopram oxalate tablet placebo 1 tablet

DRUGEscitalopram

LV232 capsule placebo 3 capsule + escitalopram oxalate tablet 1 tablet

DRUGPlacebo

LV232 capsule placebo 3 capsule + escitalopram oxalate tablet placebo 1 tablet


Locations(1)

Shanghai Mental Health Center Ethics Committee

Shanghai, China

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NCT06828887


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