Combining mindfulness training with brain stimulation for depression
Mindfulness Engaged Neurostimulation for Depression
This study is testing a new treatment for people with treatment-resistant depression by combining brain stimulation with mindfulness training to see if it helps improve their mood and brain function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06399406 on ClinicalTrials.gov |
What this trial studies
This study aims to create a new treatment for treatment resistant depression (TRD) by combining intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), with digital mindfulness training. The goal is to engage brain plasticity, improve cognitive function, and reduce depression symptoms in individuals who have not responded to traditional antidepressant therapies. The study will assess the effectiveness of this multimodal approach by measuring brain activity and depression severity in participants. It will also determine the optimal dose of the combined treatment for achieving the desired neural engagement.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with major depressive disorder who have not responded to at least one antidepressant medication.
Not a fit: Patients with active psychotic symptoms, neurological disorders, or those currently experiencing suicidal behavior may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with treatment resistant depression.
How similar studies have performed: While rTMS has shown some success in treating depression, the combination of iTBS with mindfulness training is a novel approach that has not been extensively tested.
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
La Jolla, California
- University of California San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Jyoti Mishra, PhD — University of California, San Diego
- Study coordinator: Jyoti Mishra, PhD
- Email: braine@ucsd.edu
- Phone: 8582322855
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.