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Mindfulness Engaged Neurostimulation for Depression (MEND II)

Mindfulness Engaged Neurostimulation for Depression

Who can join

Ages 18 to 65 · All sexes

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.

About the 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.

What is being tested

• Medi-TBS (combination product)

Sponsor: University of California, San Diego · Participants: 120 · Started: May 1, 2026

Contact the study team

• Jyoti Mishra, PhD · Phone: 858-232-2855

Official record on ClinicalTrials.gov — NCT07512284

Locations in the U.S.

Conditions

• Depression
• Treatment-Resistant Depressive Disorder
• Major Depressive Disorder

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.