Actively Recruiting
Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD
Led by Vigonvita Life Sciences · Updated on 2025-04-24
400
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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, risks, and agree to participate by signing consent
- Aged 18 to 65 years at screening
- Diagnosed with major depressive disorder (MDD) based on DSM-5 criteria
- Current depressive episode lasting at least 3 months for first-episode patients or 1 month for recurrent patients
- Montgomery-Asberg Depression Rating 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 dose if of childbearing potential
You will not qualify if you...
- Treatment-resistant depression or non-response to adequate escitalopram oxalate treatment
- Diagnosed with other mental disorders such as schizophrenia, bipolar disorder, anxiety, obsessive-compulsive disorder, or somatic symptom disorders
- Diagnosed with substance use disorder
- Organic mental disorders or depression caused by other medical conditions
- Depression induced by psychoactive or non-addictive substances
- Depressive symptoms caused by other diseases or mental disorders
- Reduction of 25% or more in MADRS score from screening to baseline
- At risk of suicide or suicidal behavior within 6 months prior to screening
- Severe physical illnesses such as uncontrolled hypertension, severe cardiovascular, liver, kidney, blood, endocrine, or neurological diseases
- Diseases affecting oral drug absorption like active bowel disease or intestinal obstruction
- Active cancer or cancer history within 5 years (except certain cured cancers)
- History of increased eye pressure or narrow-angle glaucoma
- Allergy to escitalopram oxalate or multiple drugs
- Use of liver enzyme-altering drugs within 4 weeks prior to randomization
- Prior vagus nerve stimulation, deep brain stimulation, modified electroconvulsive therapy within 3 months prior to randomization
- Systematic psychotherapy, transcranial magnetic stimulation, or light therapy within 1 month prior to randomization
- Antidepressant treatment within 2 weeks prior to randomization (30 days for fluoxetine)
- Use of monoamine oxidase inhibitors or certain antibiotics within 2 weeks prior to randomization
- Certain heart conditions or prolonged QT interval on ECG at screening
- Recent discontinuation of drugs that prolong QT interval
- Abnormal liver, kidney, or thyroid function tests at screening
- Positive for Treponema pallidum or HIV antibodies at screening
- Substance abuse within 3 months prior to screening
- Pregnant or breastfeeding females
- Participation in another clinical trial or use of investigational drugs within 3 months prior to screening
- Other factors judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center Ethics Committee
Shanghai, China
Actively Recruiting
Research Team
D
Duan Huaqing
CONTACT
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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