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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