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Mindfulness Engaged Neurostimulation for Depression (MEND II)

This study, called MEND II, is looking for people aged 18 to 65 with major depressive disorder that hasn't improved with at least one antidepressant medication. It's testing a new approach called Medi-TBS, which combines an FDA-approved brain stimulation therapy (repetitive transcranial magnetic stimulation, or rTMS) with digital mindfulness exercises. The goal is to see if this combination can reduce depression symptoms and improve thinking skills. Researchers will measure changes in your brain activity (specifically, pDMN alpha activity) after 4 weeks to see if the treatment is working as intended. The study is currently recruiting 120 participants.

Study design
This is an interventional study with 120 planned participants. It is a two-arm randomized controlled trial, meaning participants will be randomly assigned to receive either the new combined treatment or an active control training with iTBS.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 4 weeks, which gives an indication of the initial follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07512284

Mindfulness Engaged Neurostimulation for Depression (MEND II)

Recruiting
PHASE2Ages 18–65InterventionalTreatment
University of California, San Diego
~120 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Medi-TBS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in EEG source localized pDMN alpha activity
Measured over 4 weeks

Conditions

Depression
Treatment Resistant Depression
Major Depressive Disorder
Depressive Disorder
Depressive Symptoms

Explore related trials

Treatment resistant depressionUnipolar Depression

Where it's being run

1 sites across 1 states
California1

Who to contact

Jyoti Mishra, PhD
[email protected]
858-232-2855
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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.

What this trial measures

  • Change in EEG source localized pDMN alpha activity4 weeks

    EEG alpha band (8-12 Hz) activity source-localized to the posterior Default Mode Network (pDMN) brain region extracted on distracted trials of the Breath Attention Assessment of Mindfulness task serves as the primary neural target.