Phase II Multicenter Randomized Double-Blind Study to Find the Best Dose and Assess Safety of LV232 Capsules for Treating Major Depressive Disorder

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.

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