Mindfulness Engaged Neurostimulation for Depression (MEND II)
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: University of California, San Diego
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
San Diego
Source: ClinicalTrials.gov · NCT07512284 · last updated 2026-05-06