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

RECRUITINGPHASE2

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)

NCT06828887•Vigonvita Life Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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;
•2. Gender unrestricted, at screening: 18 years old ≤ age ≤ 65 years old;
•3. 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;
•4. 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);
•5. During the screening and baseline periods, the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) must be ≥26, and the Clinical Global Impression-Severity (CGI-S) score must be ≥4;
•6. At screening and baseline visits, the score on the first item (depressed mood) of the HAMD-17 scale must be ≥2;
•7. Female or male subjects of childbearing potential agree and commit to using effective contraception from the signing of the informed consent form until 3 months after the last administration of the trial drug.

Exclusion Criteria

•1. 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;
•2. 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.);
•3. Meeting the DSM-5 criteria for substance use disorder;
•4. Organic mental disorders, such as depression caused by hypothyroidism;
•5. Depression induced by psychoactive substances or non-addictive substances;
•6. Presence of depressive symptoms due to other diseases or other types of mental disorders;
•7. A reduction of ≥25% in the MADRS score at baseline compared to the screening period;
•8. Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) and judged by the investigator to be at risk of suicide, or having suicidal behavior within the 6 months prior to screening;
•9. Presence of severe physical illnesses deemed by the investigator as grounds for exclusion, such as uncontrolled hypertension or severe unstable cardiovascular diseases, severe liver diseases, kidney diseases, blood diseases, endocrine diseases, neurological diseases, etc.;
•10. Diseases affecting oral drug absorption, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc.;
+15 more criteria

Locations (1)

Shanghai Mental Health Center Ethics Committee

Shanghai, China

Key Dates

Start Date

April 3, 2025

Primary Completion Date

September 1, 2026

Completion Date

December 20, 2026

Last Updated

April 24, 2025

Enrollment

400

ESTIMATED participants

Conditions

MDD

Interventions

LV232 40mg

DRUG

LV232 60mg

DRUG

Escitalopram

DRUG

Placebo

DRUG

Contacts

Duan Huaqing

CONTACT

+86-18061926005 huaqing.duan@vigonvita.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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