NCT06399406Active, not recruitingPhase 2
Mindfulness Engaged Neurostimulation for Depression
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 30 Apr 2024
- Start date
- 15 May 2024
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- University of California, San Diego
- Diseases
- Depression
- NCT number
- NCT06399406
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 15 May 2024 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant neurological disorder or a history of a seizure disorder.
Other illness
- Any psychotic disorder or current active psychotic symptoms.
- Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.
Other
- Inability to provide informed consent.
- Medically unstable patients.
- Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Patients who are pregnant or breastfeeding.
- Contraindication to MRI scanning.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.