Who is eligible for clinical trial NCT07512284?

Participants must meet protocol criteria for Depression. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07512284 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-01

Mindfulness Engaged Neurostimulation for Depression (MEND II) (NCT07512284)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of California, San Diego

🩺 Plain-English Summary (8th-Grade Level)

Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of \~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (9 items).

Location: UC San Diego Health Psychiatry — San Diego, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder.
At least one failed antidepressant medication trial at level 3 in the Antidepressant -Treatment History Form: Short Form (ATHF-SF) classification.
Montgomery-Åsberg Depression Rating Scale (MADRS) Score \>19 (moderate - severe depression).
No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
Demonstrated capacity to give informed consent.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Inability to provide informed consent.
Medically unstable patients.
Concomitant neurological disorder or a history of a seizure disorder.
Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)
Patients who are pregnant or breastfeeding.
Any psychotic disorder or current active psychotic symptoms.
Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.
Contraindication to MRI scanning.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

UC San Diego Health Psychiatry — San Diego, California

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗