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

NCT06828887 | Recruiting Phase 2

• 1 other identifier: LV232-MDD-II-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

MDD

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)

  The MADRS is a clinician-rated scale used to evaluate depressive symptoms over the preceding week. Participants are assessed on 10 items-including feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest-each scored on a 7-point scale (0 = no symptoms, 6 = maximum severity). The total score ranges from 0 to 60, with higher scores indicating greater depression severity. A negative change in score signifies improvement. Change = (Week 8 post-dose score - baseline week 0 score). at the end of treatment (week 8)

  Baseline and week 8

Secondary Outcomes (13)

• Change from baseline in Hamilton Depression Scale (HAMD-17) at week 8

  Baseline, week 8

• Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 8

  Baseline, week 8

• Change from baseline in CGI-S score at week 8

  Baseline and week 8

• CGI-I score at week 8

  Baseline, week 8

• Change from baseline in PHQ-9 score at week 8

  Baseline, week 8

Study Arms (3)

LV232 capsules

EXPERIMENTAL

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

Drug: LV232 40mg; Drug: LV232 60mg

Escitalopram

ACTIVE COMPARATOR

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

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LV232 40mg DRUG

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

Also known as: Low-dose group

LV232 capsules

LV232 60mg DRUG

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

Also known as: High-dose group

LV232 capsules

Escitalopram DRUG

LV232 capsule placebo 3 capsule + escitalopram oxalate tablet 1 tablet

Also known as: Active Comparator

Escitalopram

Placebo DRUG

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

Also known as: Placebo Comparator,

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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;
• At screening and baseline visits, the score on the first item (depressed mood) of the HAMD-17 scale must be ≥2;
• 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.

You may not qualify if:

• 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;
• Depression induced by psychoactive substances or non-addictive substances;
• Presence of depressive symptoms due to other diseases or other types of mental disorders;
• A reduction of ≥25% in the MADRS score at baseline compared to the screening period;
• 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;
• Diseases affecting oral drug absorption, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc.;
• Active malignancy or a history of malignancy within 5 years prior to screening (except for completely resected and cured squamous cell carcinoma, cervical carcinoma in situ, etc.);
• History of increased intraocular pressure or narrow-angle glaucoma;
• Individuals with allergic constitution, such as those allergic to two or more drugs or known to be allergic to escitalopram oxalate;
• Use of drugs that alter the activity of liver enzymes (CYP2C19 and CYP2D6) within 4 weeks (or 5 half-lives, whichever is longer) prior to randomization (see Appendix 2);
• Previous treatment with vagus nerve stimulation (VNS) and deep brain stimulation (DBS), or modified electroconvulsive therapy (MECT) within 3 months prior to randomization, or systematic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy), transcranial magnetic stimulation (TMS), and light therapy within 1 month prior to randomization, or judged by the investigator to currently require such treatments;
• Systematic antidepressant treatment within 2 weeks prior to randomization (not less than 30 days for fluoxetine), or discontinuation of psychotropic drugs for less than 5 half-lives prior to randomization (except for stable doses of sleep aids received within 4 weeks prior to randomization, including benzodiazepines (limited to estazolam, alprazolam, and oxazepam) and non-benzodiazepines);

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Mental Health Center Ethics Committee

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Population Groups; Escitalopram

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Li Huafang

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duan Huaqing

CONTACT

+86-18061926005; huaqing.duan@vigonvita.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Triple (ParticipantCare ProviderInvestigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 17, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)