Mindfulness Engaged Neurostimulation for Depression (MEND II)
Recruiting · NCT07512284 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed across 1 US state.
- UC San Diego Health Psychiatry - San Diego, California, United States