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Investigational TMS Treatment for Depression

Primary Purpose

Depression, Treatment Resistant Depression

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS
Sponsored by
White River Junction Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, trd, treatment-resistant depression, TMS

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • psychiatric comorbidities

Sites / Locations

  • White River Junction VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Arm

Treatment Arm

Arm Description

Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.

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.

Outcomes

Primary Outcome Measures

Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2017
Last Updated
May 10, 2021
Sponsor
White River Junction Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03175887
Brief Title
Investigational TMS Treatment for Depression
Official Title
Dorsolateral Versus Medial Prefrontal TMS for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
PI's discretion due to needing to modify study protocol.
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
White River Junction Veterans Affairs Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Treatment Resistant Depression
Keywords
depression, trd, treatment-resistant depression, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.
Arm Title
Treatment Arm
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
TMS
Intervention Description
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.
Primary Outcome Measure Information:
Title
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
Description
Depressive symptoms will be 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21-70 years old inadequate response to one current antidepressant medication currently depressed Exclusion Criteria: psychiatric comorbidities
Facility Information:
Facility Name
White River Junction VA Medical Center
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigational TMS Treatment for Depression

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