Magnetic Brain Stimulation Combined With Mindfulness Training for Treatment-Resistant Depression
Tests magnetic brain stimulation plus digital mindfulness training in adults with treatment-resistant depression.
Plain-language title generated from the registry record
Registry title: Mindfulness Engaged Neurostimulation for Depression (MEND II)
Key facts
- Where
- San Diego, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07512284, who can take part
Where in United States
- UC San Diego Health PsychiatrySan Diego, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of California, San Diego
- Trial code
- NCT07512284
- Record updated
- 6 May 2026
- Original description
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.Read full original descriptionShow less
Mindfulness Engaged Neurostimulation for Depression
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.
Inclusion: 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: Concomitant neurological disorder or a history of a seizure disorder; Any psychotic disorder or current active psychotic symptoms; Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS; Inability to provide informed consent; Medically unstable patients; Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS); Patients who are pregnant or breastfeeding; Contraindication to MRI scanning.