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

NCT06828887 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Li Huafang · Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2026-09-01
Completion
2026-12-20

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828887 on ClinicalTrials.gov