Status:

COMPLETED

rTMS for Depression

Lead Sponsor:

Northwell Health

Conditions:

Depression

Eligibility:

All Genders

18-80 years

Brief Summary

This is a longitudinal observational study, where we will track outcomes in patients undergoing 5 weeks of FDA approved right DLPFC rTMS treatment.

Eligibility Criteria

Inclusion

  • Male or female subjects 18 to 80 years of age
  • DSM V diagnosis of a major depressive episode Subjects must have an initial score of at least 20 on the HAMD at screen
  • rTMS is clinically indicated
  • Patient is competent to provide informed consent

Exclusion

  • Lifetime DSM-V diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the DSM-V
  • Current (within the last year) diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression and is the primary diagnosis
  • Current diagnosis of delirium, dementia, or amnestic amnesiac disorder
  • Diagnosis of mental retardation
  • Baseline Mini Mental State Exam (MMSE) score \< 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less
  • Any active general medical condition or CNS disease which can affect cognition or response to treatment
  • Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week as indicated by self-report.
  • ECT or rTMS within three months
  • Pregnancy as indicated by self-report
  • MRI contraindications
  • Implanted electronic device or metal implant in the head and neck region (DBS, cochlear implant, etc)
  • Change in the dose of psychotropic medications within the past week
  • Inclusion Criteria for healthy volunteers:
  • Male or female between age 18 and 80
  • Patient is competent to provide informed consent
  • Exclusion Criteria for healthy volunteers:
  • Lifetime history of major chronic mental illness, such as schizophrenia, major depression, or bipolar disorder
  • Lifetime history of psychiatric hospitalization because of any mental illness Mental illness, other than depression, that needed psychological or pharmacological treatment in the past
  • Any neurodevelopmental or neurodegenerative disease, or stroke or positive findings on past head CT or brain MRI
  • Pregnancy
  • Hamilton Rating Scale for Depression (HRSD-17) is more than 7
  • MRI contraindications

Key Trial Info

Start Date :

August 23 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 19 2022

Estimated Enrollment :

54 Patients enrolled

Trial Details

Trial ID

NCT06484413

Start Date

August 23 2016

End Date

April 19 2022

Last Update

July 3 2024

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