RECRUITING

Mindfulness Engaged Neurostimulation for Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mindfulness Engaged Neurostimulation for Depression

Quick Facts

Study Start:2024-05-15
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06399406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * At least one failed antidepressant medication trial at level 3 in the Antidepressant Treatment History Form: Short Form (ATHF-SF) classification.
  3. * Montgomery-Åsberg Depression Rating Scale (MADRS) Score \>19 (moderate - severe depression).
  4. * No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
  5. * Demonstrated capacity to give informed consent.
  1. * Inability to provide informed consent.
  2. * Medically unstable patients.
  3. * Concomitant neurological disorder or a history of a seizure disorder.
  4. * Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)
  5. * Patients who are pregnant or breastfeeding.
  6. * Any psychotic disorder or current active psychotic symptoms.
  7. * Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.
  8. * Contraindication to MRI scanning.

Contacts and Locations

Study Contact

Jyoti Mishra, PhD
CONTACT
8582322855
braine@ucsd.edu

Principal Investigator

Jyoti Mishra, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of California San Diego
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Jyoti Mishra, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-15
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • rTMS
  • mindfulness
  • depression

Additional Relevant MeSH Terms

  • Depression
  • Treatment Resistant Depression
  • Major Depressive Disorder
  • Depressive Disorder