Recruiting
Phase 2

iTBS & Mindfulness

Sponsor:

UCLA

Code:

NCT07512284

Conditions

Depression

Treatment Resistant Depression

Major Depressive Disorder

Depressive Disorder

Depressive Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Medi-TBS

Study Details

Brief 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.

Conditions

Depression

Treatment Resistant Depression

Major Depressive Disorder

Depressive Disorder

Depressive Symptoms

Study ID

NCT07512284

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medi1-TBS

This arm will receive a multimodal treatment with a digital mindfulness training focused on attention to breathing for up to 10 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region.

active comparator: Medi3-TBS

This arm will receive a multimodal treatment with a digital mindfulness training focused on intermittent deep breathing for up to 10 min session dose for up to 20 sessions combined with neuro-navigated iTBS type of rTMS (for 20 treatments over 4 weeks) targeting the left dorsolateral prefrontal cortex (DLPFC) brain region.

Interventions

Medi-TBS

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

Primary outcome measure

  • Change in EEG source localized pDMN alpha activity [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Jyoti Mishra, PhD

858-232-2855braine@ucsd.edu

Locations

UC San Diego Health Psychiatry

Recruiting

San Diego, California, United States, 92037

Contacts

Jyoti Mishra, PhD

8582322855braine@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-05-06.