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

To take part in this study, you would need to be between 18 and 65 years old. You must have been diagnosed with moderate or severe depression that has lasted for at least three months, and you shouldn't have any mental health conditions that involve psychosis, like schizophrenia or bipolar disorder.

Crucially, your depression must be considered 'treatment-resistant'. This means you will have tried at least two, but no more than five, different antidepressant medications for your current depressive episode, and they haven't worked well enough for you.

There are also some reasons why you couldn't join. For instance, if you have a history of serious alcohol or drug use in the past year, or have had thoughts of harming yourself with an intent to act in the last six months. Also, certain serious heart conditions would prevent participation, as would other significant health issues that might make taking part unsafe or interfere with the study results.

If you join this study, it will involve roughly 142 people. You would be randomly put into one of two groups: one group receives the VLS-01 film, and the other receives a dummy film (placebo). Neither you nor the study doctors would know which you are receiving, which helps ensure fair results.

You would receive the film to use inside your cheek twice, with two weeks between each dose. For 12 weeks after the second dose, your mood and symptoms would be carefully monitored. After this period, everyone in the study would then receive a dose of the VLS-01 film, but it would be either one of two different strengths. Your safety and how well the treatment is working will be checked two weeks after this final dose. The overall study will involve several visits to the clinic for assessments.