Investigational Psychedelic Medicine for Treatment-Resistant Depression

This study is researching VLS-01 to see if it can help people with depression who haven't improved on other treatments. The study is split into two main parts. In the first part, participants will receive 2 doses of VLS-01 or placebo. In the second part, participants will receive either 60mg or 120mg of VLS-01. Both parts of the study are designed to assess safety and effectiveness and in each part, what you receive will not be known to you (VLS-01 vs placebo and VLS-01 60mg vs 120mg)

Antidepressants will need to be discontinued during the trial period. You may need to stop certain other medications such as antipsychotics, lithium, stimulants, or some mood stabilizers after discussing with the study clinic. If you take other medications, the study team will review them with you to confirm what is safe to continue.

VLS-01 has been studied in Phase 1 clinical trials in humans, where it was shown to be generally well tolerated and produced rapid, time-limited psychedelic effects. These early human studies supported moving forward to this Phase 2 trial to further evaluate its effects in people with treatment-resistant depression.

VLS-01 is different from most depression treatments because it's given as a small strip that dissolves in the mouth during a supervised clinic visit, rather than as a daily pill taken at home. It's designed to act quickly and is only given a limited number of times, unlike traditional antidepressants that are taken every day for long periods.