Trials / Not Yet Recruiting
Not Yet RecruitingNCT07512284
Mindfulness Engaged Neurostimulation for Depression (MEND II)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Depression
- Treatment Resistant Depression
- Major Depressive Disorder
- Depressive Disorder
- Depressive Symptoms
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Medi-TBS | The multimodal intervention involves combining FDA-approved repetitive transcranial magnetic stimulation (rTMS) with digital mindfulness exercises. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2029-04-30
- Completion
- 2029-04-30
- First posted
- 2026-04-06
- Last updated
- 2026-04-06
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07512284. Inclusion in this directory is not an endorsement.