Investigational TMS Treatment for Depression

• ClinicalTrials.gov Identifier: NCT03175887
• Recruitment Status: Withdrawn
• First Posted: June 5, 2017
• Last Update Posted: May 13, 2021
• Sponsor: White River Junction Veterans Affairs Medical Center
• Information provided by (Responsible Party): Paul Holtzheimer, White River Junction Veterans Affairs Medical Center

Tracking Information

• First Submitted Date: May 3, 2017
• First Posted Date: June 5, 2017
• Last Update Posted Date: May 13, 2021
• Estimated Study Start Date: September 2021
• Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigational TMS Treatment for Depression
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Depression
• Treatment Resistant Depression

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 10, 2021): 0
• Original Estimated Enrollment (submitted: June 2, 2017): 40
• Estimated Study Completion Date: September 2022
• Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• psychiatric comorbidities

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03175887
• Other Study ID Numbers: 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

• 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: White River Junction Veterans Affairs Medical Center
• Original Study Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: White River Junction Veterans Affairs Medical Center
• Verification Date: May 2021