VLS-01 for Treatment-Resistant Depression
About This Clinical Trial
What is being tested? The Elumina study is researching a study medicine for people with TRD to learn if it may improve their symptoms of depression. The investigational medicine will cause temporary psychedelic effects and may offer a short-term treatment plan for TRD as it is thought to improve depression symptoms.
What is a research study? Research studies are designed to test investigational medicines to understand how safe they are and how well they work. Every medicine approved today, including those for depression, must first go through testing in research studies before they receive approval. Joining a research study is your choice and if you decide to take part, you may choose to leave at any time and for any reason.
What to Expect as a Trial Participant
- Participants will receive a total of 3 doses of study treatment - investigational medicine or placebo - during the Elumina study. They will be randomly assigned to receive either:
- 2 doses of placebo + 1 dose of investigational medicine OR
- 3 doses of investigational medicine
- Both the investigational medicine and placebo are given as a thin piece of “dissolving film” placed in the mouth.
- Participants will receive psychological support sessions through their participation in the Elumina study.
- You will be in this study for about 5 months. You will attend about 15 visits, either at the clinic or by phone call during the study.
Am I Eligible?
This study is enrolling adults aged 18 to 65 who:
- Are diagnosed with major depressive disorder (MDD) and are currently experiencing a depressive episode.
- Have tried 2 to 5 antidepressant medications for your current depressive episode.
- Do not have a diagnosis of PTSD, OCD, or a psychotic disorder such as schizophrenia.
There are other requirements which the study team will discuss with you.
Ready to Take the Next Step?
Call for information on Psychedelic-Assisted Clinical Trials: 310-996-8966
Schedule a consultant and find out if participating in a clinical trial or other care option is right for you.
Contact Us to Learn More & See If You Qualify
Crisis Support Disclaimer
Notice: If you or someone you know is in crisis, call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255), or text the Crisis Text Line (text HELLO to 741741).