Actively Recruiting
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Dose-Finding Trial of LV232 Capsules for Major Depressive Disorder
Led by Vigonvita Life Sciences · Updated on 2026-05-20
400
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LV232 capsules for treating major depressive disorder (MDD) in a multicenter, randomized, double-blind, placebo- and active-controlled Phase II clinical trial. The study aims to find the best dose of LV232, assess its preliminary effectiveness and safety, and support the design of future Phase III trials. The trial includes adults aged 18 to 65 who have experienced a depressive episode and meet specific diagnostic criteria. Participants are randomly assigned to one of four groups receiving either LV232 capsules at 40 mg or 60 mg daily, an active control drug (Escitalopram), or a placebo. The treatment lasts for 8 consecutive weeks with daily administration. The study groups receive matching capsules or tablets to maintain blinding. During the trial, participants will attend visits for assessments including depression and anxiety rating scales, cognitive and functional questionnaires, and safety monitoring through adverse event tracking and laboratory tests. The main outcome is the change in depression severity measured by the Montgomery-Asberg Depression Rating Scale at week 8. The total participation spans the 8-week treatment period, with evaluations at baseline and week 8.
CONDITIONS
Brief Title
Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the trial purpose and consent to participate voluntarily
- Age between 18 and 65 years at screening
- Diagnosed with major depressive disorder according to DSM-5 criteria
- Current depressive episode lasting at least 3 months for first episode or 1 month for recurrence
- Montgomery-Asberg Depression Scale (MADRS) score of 26 or higher and Clinical Global Impression-Severity (CGI-S) score of 4 or higher at screening and baseline
- Score of 2 or higher on the depressed mood item of the HAMD-17 scale at screening and baseline
- Agree to use effective contraception from consent signing until 3 months after last study drug administration if of childbearing potential
You will not qualify if you...
- Treatment-resistant depression or failure to respond to escitalopram treatment
- Diagnosed with other mental disorders per DSM-5 (e.g., schizophrenia, bipolar disorder, anxiety disorders)
- Substance use disorder as defined by DSM-5
- Organic mental disorders causing depression (e.g., hypothyroidism)
- Depression caused by psychoactive or non-addictive substances
- Depressive symptoms from other diseases or mental disorders
- Significant reduction in MADRS score before baseline compared to screening
- Suicide risk or suicidal behavior within 6 months prior to screening
- Severe physical illnesses like uncontrolled hypertension, liver, kidney, blood, endocrine, or neurological diseases
- Diseases affecting oral drug absorption
- Active cancer or cancer history within 5 years (except certain fully treated cancers)
- History of increased eye pressure or narrow-angle glaucoma
- Allergies to multiple drugs or escitalopram
- Recent use of certain liver enzyme-altering drugs
- Recent brain stimulation therapies or certain psychotherapies
- Recent systematic antidepressant treatment or psychotropic drug discontinuation
- Use of monoamine oxidase inhibitors or related drugs within 2 weeks prior to randomization
- Certain heart conduction abnormalities or prolonged QT interval
- Elevated liver enzymes or kidney function tests
- Positive tests for syphilis or HIV
- Substance abuse within 3 months prior to screening
- Pregnancy or breastfeeding
- Participation in other clinical trials within 3 months prior
- Any other factors judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive LV232 capsules (40 mg or 60 mg), escitalopram, or placebo once daily for 8 consecutive weeks to evaluate the efficacy and safety for major depressive disorder.
Baseline visit and follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center Ethics Committee
Shanghai, China
Actively Recruiting
Research Team
D
Duan Huaqing
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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