Clinical trials / NCT07512284
Recruiting

Mindfulness Engaged Neurostimulation for Depression (MEND II)

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…

ClinicalTrials.gov IDNCT07512284
PhasePHASE2
Enrollment120
SponsorUniversity of California, San Diego
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Depression, Treatment Resistant Depression, Major Depressive Disorder, Depressive Disorder, Depressive Symptoms

About this study

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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.