DepressionNCT06484413
rTMS for Depression
An observational study of Depression, run by Northwell Health.
Trial summary
This is a longitudinal observational study, where we will track outcomes in patients undergoing 5 weeks of FDA approved right DLPFC rTMS treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 23 Aug 2016to 19 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
- Male or female between age 18 and 80
- Patient is competent to provide informed consent
Who cannot join
- 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
Show all 18Show fewer
- 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
- 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
About this study
Official title: Repetitive Transcranial Magnetic Stimulation 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.
- Conditions
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| rTMS Group | received rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS
Montgomery-Asberg Depression Rating Scale
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start23 Aug 2016
- Primary completion25 Feb 2020
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484413
- Sponsor's protocol ID
- HS16-0437
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Depression
- ClinicalTrials.gov ID
- NCT06484413
- Acronym / sponsor ID
- HS16-0437
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a longitudinal observational study, where we will track outcomes in patients undergoing 5 weeks of FDA approved right DLPFC rTMS treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS Group | – | –received rTMS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
- Male or female between age 18 and 80
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MADRS
Time frame: 5 weeks
Montgomery-Asberg Depression Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Northwell Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.