Actively Recruiting
Maintenance rTMS for Depression (Maitr-De)
Led by University of California, San Diego · Updated on 2026-04-29
75
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Maintenance rTMS for Depression (Maitr-De)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a Major Depressive Episode during the depression episode treated with acute rTMS
- Achieved response or remission from initial depression after acute rTMS, defined by MADRS score criteria
- Completed at least 15 rTMS treatment sessions in the initial course
- Aged between 18 and 80 years at screening
- Able to read, understand, and provide written informed consent in English
- In good general health based on medical history
- Willing to follow lifestyle considerations during the study
- If of child-bearing potential, negative pregnancy test confirmed at screening
You will not qualify if you...
- Pregnancy
- History or current psychotic disorder or depression with psychotic features
- Severe borderline personality disorder
- Diagnosis of Intellectual Disability or Autism Spectrum Disorder
- Moderate or severe substance use disorder or signs of acute withdrawal
- Clinically significant suicidal thoughts with a plan
- More than 8 sessions of ECT without meaningful response in current episode
- Recent or concurrent use of rapid-acting antidepressants (e.g., ketamine) or ECT within last 30 days
- History of significant neurological diseases or brain injury
- Untreated or insufficiently treated endocrine disorders
- Contraindications to rTMS such as metal in head or seizure history
- Treatment with investigational drugs or interventions during the study
- Relapse between baseline and screening (MADRS ≥20 and 25% increase)
- Requirement for benzodiazepines over lorazepam 2 mg/day or certain anticonvulsants (except gabapentin, pregabalin, lamotrigine)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of California, San Diego
San Diego, California, United States, 92127
Actively Recruiting
2
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
3
Australian National University
Canberra, Australian Capital Territory, Australia, 2601
Actively Recruiting
Research Team
I
Interventional Psychiatry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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