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Recruiting NCT07512284

Mindfulness Engaged Neurostimulation for Depression (MEND II)

Phase II Interventional Depression Treatment Resistant Depression Major Depressive Disorder Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medi-TBS.
Who it may be relevant to
Registry conditions: Depression, Treatment Resistant Depression, Major Depressive Disorder, Depressive Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mindfulness Engaged Neurostimulation for Depression

Overview

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.

Detailed description

This study aims to develop a novel multimodal treatment for treatment resistant depression (TRD), which combines intermittent theta burst stimulation (iTBS), a type of FDA-approved rTMS protocol, with digital mindfulness training. We propose that this multimodal treatment will suppress posterior Default Mode Network (pDMN) brain activity as measured with electroencephalography (primary outcome and neural target), as well as enhance cognition and alleviate depression symptoms in patients with TRD (secondary outcomes). The study will conduct a two-arm randomized controlled trial to demonstrate neural target engagement by the multimodal iTBS + digital mindfulness training relative to an active control training combined with iTBS.

Interventions

  • Combination product Medi-TBS
    The multimodal intervention involves combining FDA-approved repetitive transcranial magnetic stimulation (rTMS) with digital mindfulness exercises.

Primary outcome measures

  • Change in EEG source localized pDMN alpha activity [Time frame: 4 weeks]
Secondary outcome measures (3)
  • Change in Selective Attention [Time frame: 4 weeks]
  • Change in Flanker Inhibition [Time frame: 4 weeks]
  • Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS) [Time frame: 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UC San Diego Health Psychiatry — San Diego

Identifiers

NCT: NCT07512284 · MEND II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗