A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
Recruiting · 40 sites across 20 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Be age 18 to 65 when signing consent.
- •Have recurrent moderate or severe major depressive disorder (MDD) without psychotic features, or single-episode MDD lasting at least 3 months without psychotic features, and be having a major depressive episode now.
- •Have the first episode of MDD start before age 55.
- •Not have improved after trying at least two antidepressant medicines (but no more than five) at adequate doses and durations for this episode, based on the MGH-Antidepressant Treatment Response Questionnaire (MGH-ATRQ).
- •Be able to sign consent and follow the study rules.
🚫 You may not be able to join if…
- •Have a current or past DSM-5-TR diagnosis of schizophrenia spectrum/other psychotic disorders, substance/medication-induced psychotic disorder, bipolar-related disorder, or any disorder with psychotic features.
- •Have moderate or severe substance use disorder (drugs, alcohol, or tobacco) within 6 months before screening, or within the past 1 year before screening.
- •Have suicidal ideation with some intent to act within 6 months before screening, or a history of suicidal behavior within 1 year before screening.
- •Have clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease/conditions, including (for example) unstable angina, heart attack, congestive heart failure, heart rhythm problems, valvular heart disease, obstructive coronary artery disease, hypertension, and other listed conditions (including risk factors for long QT syndrome).
- •Have an allergy or hypersensitivity to VLS-01 or ingredients in the film.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–65
- ✓Have Depression
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06524830 · Locations: Arizona · Arkansas · California · Colorado · Florida · Georgia · Illinois · Maryland · Massachusetts · Minnesota · Missouri · New Jersey · New York · Ohio · Pennsylvania · Texas · Utah · Washington · New South Wales · Victoria