Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT07512284

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

UC San Diego Health Psychiatry

San Diego, California, United States, 92037

Actively Recruiting

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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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Mindfulness Engaged Neurostimulation for Depression (MEND II) | DecenTrialz