Phase 2 Study to Evaluate VLS-01 Buccal Film for Safety and Effectiveness in Adults With Treatment Resistant Depression

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film VLS-01-BU in adults with treatment resistant Major Depressive Disorder TRD. This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants depressive symptoms will be regularly monitored using the Montgomery-sberg Depression Rating Scale MADRS from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.

A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)