This study explores a new medicine called VLS-01 Buccal Film for people with tough-to-treat depression, known as Major Depressive Disorder (MDD). The buccal film is a small, dissolvable strip placed inside the mouth. Participants will receive either the VLS-01 film or a placebo (a fake treatment), and their depression symptoms will be watched over 12 weeks. The study is "double-blind," meaning neither the participants nor the researchers know who gets the real treatment or placebo, which helps ensure fair results.
About 142 adults aged 18 to 65 will take part. They will have three doses over the study, and the final safety check happens two weeks after the last dose. The study aims to see if VLS-01 helps reduce depression symptoms compared to a placebo and to ensure it is safe and tolerable for participants. This study is not suitable for those with certain medical conditions or recent serious substance use.
- The study lasts 12 weeks with three treatment doses.
- Participants must be 18-65 years old with specific depression history.
- Study visits include safety checks and symptom monitoring.