Mindfulness‑augmented brain stimulation for treatment‑resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 randomized controlled trial compares intermittent theta burst stimulation (iTBS) plus digital mindfulness training to iTBS with an active control training in adults with treatment‑resistant major depression. The primary outcome is suppression of posterior Default Mode Network (pDMN) activity measured by electroencephalography (EEG), with secondary outcomes of cognitive performance and depressive symptom change (MADRS). Participants must have a current major depressive episode, at least one failed adequate antidepressant trial, and moderate-to-severe symptoms. Treatment sessions and outcome assessments are delivered in person at UC San Diego with participants randomized to one of two arms.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC San Diego Health Psychiatry
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Jyoti Mishra, PhD
• Email: braine@ucsd.edu
• Phone: 858-232-2855

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.