Recruiting

LV232 Capsules for Major Depressive Disorder

What is being tested

LV232 40mg

+ LV232 60mg

+ Escitalopram

Drug

Who is being recruted

From 18 to 65 Years

+32 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: April 2025

See protocol details

Summary

Principal SponsorVigonvita Life Sciences

Study ContactDuan Huaqing

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 3, 2025

Actual date on which the first participant was enrolled.

This clinical trial investigates how effective and safe a new medication, LV232 capsules, is for treating people with major depressive disorder (MDD). MDD is a serious mental health condition that affects many people, causing persistent feelings of sadness and loss of interest. The study aims to determine if LV232 capsules can provide better outcomes than a placebo or existing treatments. By identifying the most effective dose, the study seeks to improve treatment options for those suffering from MDD, potentially offering a new way to manage this challenging condition. Participants in the study will be divided into five groups, each receiving a different treatment: two different doses of LV232 capsules, a placebo, and an active control treatment. Each participant will take their assigned treatment once a day for eight weeks. Researchers will monitor the participants to see how their symptoms change and to ensure the safety of the treatment. This study will help determine the best dose of LV232 and compare its effects to other treatments available, offering insights into new ways to help those with MDD.

Official TitleMulticenter,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)

NCT06828887

Principal SponsorVigonvita Life Sciences

Study ContactDuan Huaqing

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

Fully understand the purpose, content, and potential adverse reactions of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, able to complete the entire trial process as required and comply with the trial regulations;

Gender unrestricted, at screening: 18 years old ≤ age ≤ 65 years old;

Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depression according to the Mini International Neuropsychiatric Interview (M.I.N.I. 7.0.2), currently experiencing a single or multiple episodes;

For first-episode patients, the duration of the current depressive episode must be ≥3 months; for recurrent patients, the duration of the current depressive episode must be ≥1 month (each month is counted as 30 days, the same applies below);

Show More Criteria

25 exclusion criteria prevent from participating

Treatment-resistant depression (failure to respond to an adequate dose and duration of treatment, at least 8 weeks, with two antidepressants of different mechanisms) or failure to respond to an adequate dose and duration of treatment with escitalopram oxalate;

Meeting the diagnostic criteria for other mental disorders as per DSM-5 (such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, generalized anxiety disorder, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc.);

Meeting the DSM-5 criteria for substance use disorder;

Organic mental disorders, such as depression caused by hypothyroidism;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Capsule, 40 mg or 60 mg, administered orally once daily for 8 consecutive weeks

Group II

Active Comparator

Tablet, 10 mg , administered orally once daily for 8 consecutive weeks

Group III

Placebo

Capsule/Tablet, administered orally once daily for 8 consecutive weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shanghai Mental Health Center Ethics Committee

Shanghai, ChinaOpen Shanghai Mental Health Center Ethics Committee in Google Maps

Recruiting

One Study Center