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OpenTrials
Completed

NCT Number: NCT06484413

rTMS for Depression

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. MADRS

    Time frame: 5 weeks

    Montgomery-Asberg Depression Rating Scale

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation for Depression

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.