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Investigational TMS Treatment for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03175887
Recruitment Status : Withdrawn (PI's discretion due to needing to modify study protocol.)
First Posted : June 5, 2017
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Paul Holtzheimer, White River Junction Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE June 5, 2017
Last Update Posted Date May 13, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2017)
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. ]
Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigational TMS Treatment for Depression
Official Title  ICMJE Dorsolateral Versus Medial Prefrontal TMS for Depression
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Treatment Resistant Depression
Intervention  ICMJE Device: TMS
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.
Study Arms  ICMJE
  • Experimental: Intervention Arm
    Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.
    Intervention: Device: TMS
  • 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.

    Intervention: Device: TMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 10, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2017)
40
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 21-70 years old
  • inadequate response to one current antidepressant medication
  • currently depressed

Exclusion Criteria:

  • psychiatric comorbidities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03175887
Other Study ID Numbers  ICMJE D17107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Paul Holtzheimer, White River Junction Veterans Affairs Medical Center
Original Responsible Party Paul Holtzheimer, Dartmouth-Hitchcock Medical Center, Director of Mood Disorders Service
Current Study Sponsor  ICMJE White River Junction Veterans Affairs Medical Center
Original Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account White River Junction Veterans Affairs Medical Center
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP