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Mindfulness Engaged Neurostimulation for Depression (MEND II)

NCT07512284 · University of California, San Diego
In plain English

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Official title
Mindfulness Engaged Neurostimulation for Depression
About this study
This study aims to develop a novel multimodal treatment for treatment resistant depression (TRD), which combines intermittent theta burst stimulation (iTBS), a type of FDA-approved rTMS protocol, with digital mindfulness training. We propose that this multimodal treatment will suppress posterior Default Mode Network (pDMN) brain activity as measured with electroencephalography (primary outcome and neural target), as well as enhance cognition and alleviate depression symptoms in patients with TRD (secondary outcomes). The study will conduct a two-arm randomized controlled trial to demonstrate neural target engagement by the multimodal iTBS + digital mindfulness training relative to an active control training combined with iTBS.
Eligibility criteria
Inclusion Criteria: * 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 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.
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-05-01
Estimated completion: 2029-04-30
Last updated: 2026-05-06
Interventions
Combination Product: Medi-TBS
Primary outcomes
  • Change in EEG source localized pDMN alpha activity (4 weeks)
Sponsor
University of California, San Diego · other
Contacts & investigators
ContactJyoti Mishra, PhD · contact · braine@ucsd.edu · 858-232-2855
All locations (1)
UC San Diego Health PsychiatryRecruiting
San Diego, California, United States
Mindfulness Engaged Neurostimulation for Depression (MEND II) · TrialPath