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NCT06399406 · ClinicalTrials.gov registry record · Phase 2
Mindfulness Engaged Neurostimulation for Depression
A Phase 2 study of Depression and Major Depressive Disorder, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06399406: Recruiting Phase 2 study of Depression and Major Depressive Disorder, sponsored by University of California, San Diego.
NCT06399406 is a Phase 2 study of Depression and Major Depressive Disorder that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 70 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06399406, a Phase 2 study of Depression and Major Depressive Disorder, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
EEG alpha band (8-12 Hz) activity source-localized to the posterior Default Mode Network (pDMN) brain region extracted on distracted trials of the Breath Attention Assessment of Mindfulness task serves as the primary neural target.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Medi-TBS
Study Locations (1)
California
- University of California San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
What NCT06399406 shows while recruiting
NCT06399406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Medi-TBS is the first listed.
NCT06399406 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06399406 about?
NCT06399406 is a clinical study titled "Mindfulness Engaged Neurostimulation for Depression". 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, r...
What is the current status of trial NCT06399406?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2024-05-15. Estimated completion is 2026-04-30.
What conditions does trial NCT06399406 study?
This clinical trial studies the following conditions: Depression, Major Depressive Disorder, Treatment-Resistant Depression, Depressive Disorder.
What interventions are being tested in trial NCT06399406?
The interventions under investigation include: Medi-TBS (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06399406?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06399406 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06399406's enrollment target sits among peer trials
70 407th of 679 higher than 266 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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