- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03175887
Investigational TMS Treatment for Depression
May 10, 2021 updated by: Paul Holtzheimer, White River Junction Veterans Affairs Medical Center
Dorsolateral Versus Medial Prefrontal TMS for Depression
This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
While transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC) is an FDA approved treatment for depression, a growing and converging database suggests the medial prefrontal cortex (MPFC) may be even more critical to the neurobiology of depression and antidepressant treatment response.
This study will compare the efficacy of high frequency transcranial madntic stimulation on these two sections of the brain.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Vermont
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White River Junction, Vermont, United States, 05009
- White River Junction VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 21-70 years old
- inadequate response to one current antidepressant medication
- currently depressed
Exclusion Criteria:
- psychiatric comorbidities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
Participants will receive TMS.
They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.
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Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.
|
Other: Treatment Arm
After the experimental arm, if a patient was randomized to the medial prefrontal cortex during the experimental arm and it did not work for them, they have the option of returning for a session of TMS to the FDA-approved dorsolateral prefrontal cortex. If they were assigned to the dorsolateral prefrontal cortex, they are not eligible to return for another set of treatment. |
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
Time Frame: Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention.
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Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.
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Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
May 3, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (Actual)
June 5, 2017
Study Record Updates
Last Update Posted (Actual)
May 13, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D17107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Lawson Health Research InstituteTerminated
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-
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-
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-
Bayside HealthNational Health and Medical Research Council, AustraliaCompletedMajor Depressive DisorderAustralia
-
Bayside HealthCompleted
-
Mclean HospitalMassachusetts General HospitalCompletedSchizophrenia | Schizoaffective Disorder | Bipolar Disorder IUnited States
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NYU Langone HealthWithdrawn
-
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