Mindfulness‑augmented brain stimulation for treatment‑resistant depression
Mindfulness Engaged Neurostimulation for Depression
This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT07512284 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a DSM‑5 major depressive episode who have failed at least one adequate antidepressant trial, have a MADRS score >19, and can provide informed consent are the intended participants.
Not a fit: People with active psychosis, current suicidal behavior, a seizure disorder, unstable medical conditions, or who are pregnant or breastfeeding are unlikely to be eligible and may not receive benefit.
Why it matters
Potential benefit: If successful, the combined iTBS plus mindfulness approach could raise remission rates above those typically seen with rTMS alone and improve cognitive functioning in people with treatment‑resistant depression.
How similar studies have performed: rTMS and iTBS are FDA‑approved for treatment‑resistant depression with remission rates around 30%, but combining iTBS with digital mindfulness to target pDMN activity is novel and has limited prior direct evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.