Investigational TMS Treatment for Depression

Not Applicable

Withdrawn

• Conditions: Treatment Resistant Depression; Depression
• Interventions: Device: TMS

• Registration Number: NCT03175887
• Lead Sponsor: White River Junction Veterans Affairs Medical Center

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 Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-13
• Study Start: 2021-09
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• psychiatric comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	TMS	Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.
Treatment Arm	TMS	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.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale	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.

Trial Locations

Locations (1)

White River Junction VA Medical Center; 🇺🇸 White River Junction, Vermont, United States