Mindfulness Engaged Neurostimulation for Depression (MEND II)
Mindfulness Engaged Neurostimulation for Depression
University of California, San Diego
120 participants
May 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria8
- 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.
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Interventions
The multimodal intervention involves combining FDA-approved repetitive transcranial magnetic stimulation (rTMS) with digital mindfulness exercises.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07512284