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Efficacy of Biomarker-Guided rTMS for Treatment Resistant Depression

Clinical Trial Details

Depression is the second leading cause of disability worldwide, due partly to the fact that existing antidepressants are not effective for all patients and it is often challenging to match individual patients to the treatments that are most likely to help them. This study will test a new strategy for using fMRI brain scans to predict antidepressant response and assist clinicians in choosing antidepressant treatments. Transcranial magnetic stimulation targeting one of two depression-related brain areas is most likely to benefit an individual patient. 

Key Eligibility: 

Inclusion Criteria 

  • Ages 18-65 
  • Major Depressive Disorder 
  • At least moderately severe depression 
  • Failure to respond to at least one antidepressant at an adequate dose and duration during this depressive episode 
  • Off antidepressants OR on a stable dose of antidepressants for greater than or equal to four weeks with plans to remain on this stable dose during the study 
  • Capacity to consent 
  • Ability to safely participate in an MRI 

Exclusion Criteria  

  • Imminent risk of suicide 
  • Current depressive episode great than or equal to 2 years duration 
  • Presence of primary psychiatric diagnoses other than MDD and or/comorbid GAD or phobias 
  • Evidence of cognitive impairment 
  • Significant substance use disorder within the past six months 
  • Recent onset of psychotherapy (within 8 weeks of screening) 
  • Prior exposure to any form of TMS during the current depressive episode 
  • Participated in any clinical trial with an investigational drug or device within the past 6 weeks prior to screening 
  • History of neurosurgery to treat a neurological or psychiatric disorder 
  • Evidence or history of significant neurological disorder including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorder (except benign essential tremor), epilepsy, History of seizures (except juvenile febrile seizures) or any condition/concurrent medication that could notably lower seizure threshold 
  • Current pregnancy or planning to conceive during the study 
  • Abnormal blood work for electrolytes, thyroid and liver function 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Niharika Malviya
nim4006@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1810019638

Status

Open to Enrollment

Age Group

Adult

Sponsor