Maintenance rTMS for Depression (Maitr-De)

Last updated: April 14, 2025
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression (Major/severe)

Affective Disorders

Depression

Treatment

Transcranial Magnetic Stimulation (TMS) - Standard maintenance rTMS:

Transcranial Magnetic Stimulation (TMS) - Clustered maintenance rTMS:

Transcranial Magnetic Stimulation (TMS) -- Sham maintenance rTMS

Clinical Study ID

NCT06938841
811708
  • Ages 18-80
  • All Genders

Study Summary

Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising intervention for treatment-resistant depression (TRD), yet substantial uncertainties persist regarding its efficacy as a maintenance treatment. This prospective study seeks to investigate the efficacy of maintenance rTMS in individuals with TRD who have previously responded to an acute course of rTMS. In the R61 phase of the study, we will recruit 75 participants across three study sites, the University of California San Diego, Weill Cornell Medicine, and Australian National University, into a double-blind, three-arm maintenance treatment trial. In this trial, participants will be randomized to receive either standard maintenance rTMS, clustered maintenance rTMS, or sham maintenance rTMS for a duration of 6 months. Our primary aim is to examine the efficacy of maintenance rTMS on sustaining connectivity between the dorsolateral prefrontal cortex (DLPFC) and subgenual cingulate cortex (SGC) measured through concurrent TMS and electroencephalography (TMS-EEG) at baseline and every six weeks throughout the 6-month treatment period. We will also assess changes in depressive symptom severity using clinical scales, including the Montgomery-Asberg Depression Rating Scale (MADRS) as a secondary outcome measure. It is hypothesized that stimulation with clustered maintenance rTMS will demonstrate superiority in sustaining DLPFC-SGC connectivity compared with standard maintenance rTMS and sham maintenance rTMS

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. They met criteria for a DSM-5 diagnosis of a Major Depressive Episode (MDE)during the index episode of depression for which they have received an acuterTMS treatment course.

  2. Meet criteria for either response or remission from their initial depressiveillness. The MINI assessment timeline will be adjusted to allow scoring ofillness symptoms prior to rTMS response. Response to acute course of treatmentis defined as either a MADRS score of <7, or a MADRS score of 7-19, plusevidence of having met response criteria on either the MADRS or anotherstructured depression rating scale. The response is defined as a >50% reductionin the total score from the start to the end of treatment.

  3. Their initial rTMS treatment course must have consisted of at least 15 rTMStreatment sessions.

  4. People between the ages of 18 and 80 at the time of screening. A writtenstatement from the referring physician will be required to confirm that theparticipant demonstrates the capacity to consent.

  5. Able to read, understand, and provide written, dated informed consent prior toscreening. Proficiency in English sufficient to complete questionnaires /follow instructions during TMS-EEG assessments and iTBS interventions. Statedwillingness to comply with all study procedures, including availability for theduration of the study, and to communicate with study personnel about adverseevents and other clinically important information.

  6. In good general health, as evidenced by medical history. 7. Agreement to adhereto Lifestyle Considerations throughout study duration. 8. If a person ofchild-bearing potential is: must take a pregnancy test at the screening visit,with results confirmed as negative by study staff

Exclusion

Exclusion Criteria:

  1. Pregnancy 2. History of or current psychotic disorder or depression withpsychotic features 3. Severe borderline personality disorder based on clinicalassessment. 4. Diagnosis of Intellectual Disability or Autism Spectrum Disorder

  2. Current moderate or severe substance use disorder or demonstrating signs ofacute substance withdrawal 6. Clinically significant suicidal ideation withplan 7. Any history of ECT (greater than 8 sessions) without a clinicalmeaningful response in the current episode.

  3. Recent (during the current depressive episode) or concurrent use ofrapid-acting antidepressant agent (i.e., ketamine or a course of ECT) in thelast 30 days 9. History of significant neurologic disease, including dementia,Parkinson's or Huntington's disease, brain tumor, seizure disorder, subduralhematoma, multiple sclerosis, or history of significant head trauma 10.Untreated or insufficiently treated endocrine disorder. 11. Contraindicationsto receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)

  4. Treatment with an investigational drug or other intervention within thestudy period 13. Unstable symptoms between screening and baseline as defined bya ≥ 30% change in MADRS score.

  5. Require a benzodiazepine with a dose > lorazepam 2 mg/day or equivalent or anyanticonvulsant (with the exception of Gabapentin).

Study Design

Total Participants: 75
Treatment Group(s): 3
Primary Treatment: Transcranial Magnetic Stimulation (TMS) - Standard maintenance rTMS:
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Australian National University

    Canberra, Australian Capital Territory 2601
    Australia

    Active - Recruiting

  • University of California, San Diego

    San Diego, California 92127
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

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