rTMS for Depression

NCT06484413 | Completed

• 1 other identifier: HS16-0437
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• MADRS

  Montgomery-Asberg Depression Rating Scale

  5 weeks

Study Arms (1)

rTMS Group

received rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with a major depressive episode who are referred for an acute course of rTMS as part of their standard of care will be recruited for the study. Recruitment will occur at The Zucker Hillside Hospital at Northwell Health.

You may qualify if:

• 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

You may not qualify if:

• 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
• Male or female between age 18 and 80
• Patient is competent to provide informed consent
• Lifetime history of major chronic mental illness, such as schizophrenia, major depression, or bipolar disorder

Sponsors & Collaborators

• Northwell Health: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: August 23, 2016
• Primary Completion: February 25, 2020
• Study Completion: April 19, 2022
• Last Updated: July 3, 2024

Record last verified: 2024-06