Mindfulness Engaged Neurostimulation for Depression (MEND II)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Medi-TBS

Treatment groups

120 Participants
are divided into 2 treatment groups