Investigational TMS Treatment for Depression

NCT03175887 | Withdrawn DMC FDA Device

• 1 other identifier: D17107
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Treatment Resistant Depression

Keywords

depression; trd; treatment-resistant depression; TMS

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale

  Depressive symptoms will be 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.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Device: TMS

Treatment Arm

OTHER

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.

Device: TMS

Interventions

TMS DEVICE

Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.

Intervention Arm; Treatment Arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• psychiatric comorbidities

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead

Study Sites (1)

White River Junction VA Medical Center

White River Junction, Vermont, 05009, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Mood Disorder Services

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: June 5, 2017
• Study Start: September 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)