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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 20, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Feb 1, 2026 to Sep 1, 2026 · Enrollment target: 500 to 400 · Study sites: 0 to 1 · 6 morev3 Show 9 more changesShow less
    • Primary completion date: Feb 1, 2026 to Sep 1, 2026
    • Enrollment target: 500 to 400
    • Study sites: 0 to 1
    • Completion date: Feb 20, 2026 to Dec 20, 2026
    • Start date changed from estimate of Apr 7, 2025 to Apr 3, 2025
    • Interventions: Escitalopram (Drug), LV232 20mg (Drug), LV232 40mg (Drug), LV232 60mg (Drug), Placebo (Drug) to Escitalopram (Drug), LV232 40mg (Drug), LV232 60mg (Drug), Placebo (Drug)
    • Secondary endpoints: details revised at 6 of 13 entries
    • Study description shortened, about 3 words
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Start date: Mar 1, 2025 to Apr 7, 2025v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06828887
Lead Sponsor Vigonvita Life Sciences
Conditions MDD
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov