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

Launched by ATAI THERAPEUTICS, INC. · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called VLS-01, which is a film that dissolves in the mouth, for people who have treatment-resistant depression (TRD). TRD refers to depression that hasn’t improved with at least two different antidepressant medications. The study aims to see if VLS-01 is effective, safe, and how well patients can tolerate it compared to a placebo, which is a treatment that has no active ingredients. Researchers want to understand how quickly VLS-01 works and how long its effects last.

To participate in the trial, individuals must be between 18 and 65 years old and have a diagnosis of moderate to severe depression that hasn’t responded to previous treatments. They should also have experienced their first depressive episode before the age of 55. Participants will be carefully monitored throughout the study, and they may experience some side effects, but the research team will be there to support them. It's important to note that certain individuals, such as those with specific psychiatric disorders or significant health issues, may not be eligible for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant must be 18 to 65 years of age inclusive at the time of signing the Informed Consent.
• • 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.
• • Has not responded to an adequate dose and duration of at least two and no more than five antidepressant medications for the current depressive episode, as determined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH- ATRQ).
• • 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.
• 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 a history of clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease or condition, including but not limited to unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, valvular heart disease, obstructive coronary artery disease, hypertension, hypotension, bradycardia, tachycardia, or risk factors for long QT Syndrome.
• • Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years before Screening.
• • Has any known allergy or hypersensitivity to VLS-01 or to any of the excipients in the formulation.
• • 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.
• • Has received any prohibited therapies.
• • Has clinically significant laboratory abnormalities at Screening.