Biomarker-guided rTMS for Treatment Resistant Depression

Part of paid clinical trials in Stanford, California.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04041479
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation — DEVICE
    iTBS rTMS targeting the DMPFC or left DLPFC
  • Repetitive Transcranial Magnetic Stimulation — DEVICE
    iTBS rTMS targeting the left DLPFC

Study Details

Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. The investigators are continuing to learn how to optimize outcomes from rTMS treatment. The purpose of this research project is to use brain network connectivity patterns as measured by resting state functional magnetic resonance imaging (fMRI) to confirm a way to optimize the use of rTMS to treat depression. In addition, the study aims to gain a better understanding of how rTMS influences brain networks.

Key Dates

Start date
Sep 17, 2021
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
348 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    FDA-cleared, standard-of-care iTBS repetitive Transcranial Magnetic Stimulation targeting the left dorsolateral prefrontal cortex (DLPFC), regardless of the depression subtype (biotype) determined by a magnetic resonance imaging (MRI) scan.
  • Experimental: Targeted Side Arm
    iTBS rTMS targeting the area of the brain (DLPFC or dorsomedial prefrontal cortex DMPFC)) that we hypothesize will be most effective for that subject's biotype (confirmation arm).
  • Active Comparator: Opposite Side Arm
    iTBS rTMS targeting the opposite site (DLPFC or DMPFC) than the one we hypothesize will be most effective for that subject's biotype (disconfirmation arm).

Primary Outcome Measure

Change in depression, as measured by the Hamilton Depression Rating Scale (HAMD17) [ Time Frame: Baseline and 1 Week Post Treatment (8-10 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Derrick Buchanan, PhD
[email protected]
Weill Cornell MedicineNew YorkNew York10065
Conor Liston, MD, PhD
[email protected]
(646) 962-6293

Find similar trials in Stanford, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Stanford University· Stanford, CAWeill Cornell Medicine· New York, NY

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