Investigational treatment for Depression

Introducing the Elumina Study

Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment-Resistant Depression

Adults aged 18 - 65

Depression Diagnosis

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About This Clinical Trial

Eligibility Criteria

Participant Commitment

How to Sign Up

Important Study Links

About This Clinical Trial

The Elumina study is researching a study medicine for people with TRD to learn if it may improve their symptoms of depression. Modern research has shown that psychedelic medicines may treat mental health conditions, such as 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.

Study Overview:

Condition

Treatment-Resistant Depression

Recruitment Status

Recruiting

Intervention

VLS-01-203 or VLS-01-BU Placebo

Principal Investigator

Ranji Varghese, MD

This is a Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of Repeated Doses of VLS-01 Buccal Film in Participants With Treatment Resistant Depression

Eligibility Criteria

Participant criteria for eligibility in this study.

*Even if you may not meet all the criteria, feel free to reach out using the Join Study button

Key Inclusion Criteria:

Participant must be 18 to 65 years of age.
Has a diagnosis of recurrent moderate or severe MDD without psychotic features or single- episode MDD with duration greater than or equal to 3 months without psychotic features and is currently experiencing a major depressive episode..
Onset of first episode of MDD occurred before age 55.
Have tried 2 to 5 antidepressant medications for their current depressive episode.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Do not have a diagnosis of PTSD, OCD, or a psychotic disorder such as schizophrenia.

Key Exclusion Criteria:

Has a current or prior DSM-5-TR diagnosis of a schizophrenia spectrum and other psychotic disorder, substance/medication-induced psychotic disorder, bipolar and related disorder, or any disorder with psychotic features.
Has a moderate or severe substance use disorder (drug, alcohol, or tobacco) within the 6 months before Screening and/or history of moderate or severe substance use disorder (drug alcohol) within the previous 1 year before Screening
Has a history of, or current signs and symptoms of, diseases or conditions that would make participation not be in the best interest (e.g., compromise the wellbeing) of the participant or that could prevent, limit, or confound the protocol-specified assessments.
Has suicidal ideation with some intent to act within 6 months before Screening or a history of suicidal behavior within the past 1 year before Screening.
Has recently initiated and is currently undergoing directive psychotherapy (e.g., cognitive behavioral therapy, interpersonal psychotherapy, psychodynamic psychotherapy) within the past 30 days before Screening. Participants planning to initiate individual or group therapy during the study are also not eligible.

Participant Commitment

This section outlines the commitment required for this study.

Participation is expected to last about 5 months
2 visits to check that this study is right for you
3 visits where you will receive the study treatment
10 visits where the study team will monitor your health and wellbeing

How to sign up for this study

Follow the link below to 'sign up' for inquiring study participants.
Following completion of criteria questions, please sign and submit the medical records retrieval.
Following submission with Power, a research study coordinator will reach out for an initial study screening call.

*If prompted select the trial site and study for interest in trial participation.

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