Actively Recruiting
Mindfulness Engaged Neurostimulation for Depression (MEND II)
Led by University of California, San Diego · Updated on 2026-05-06
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mindfulness Engaged Neurostimulation for Depression (MEND II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of major depressive episode (MDE) per DSM-5 in unipolar major depressive disorder
- At least one failed antidepressant medication trial at level 3 on the Antidepressant-Treatment History Form: Short Form
- Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than 19 (moderate to severe depression)
- No new or increased antidepressant therapy in the four weeks before screening
- Ability to provide informed consent
You will not qualify if you...
- Unable to provide informed consent
- Medically unstable condition
- Presence of neurological disorder or history of seizure disorder
- Current suicidal behavior per Columbia Suicide Severity Rating Scale (C-SSRS)
- Pregnant or breastfeeding
- Any psychotic disorder or active psychotic symptoms
- Presence of intracranial implants, medical devices, or conditions unsafe for TMS
- Contraindication to MRI scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UC San Diego Health Psychiatry
San Diego, California, United States, 92037
Actively Recruiting
Research Team
J
Jyoti Mishra, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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