Magnetic Brain Stimulation for the Treatment of Adult Depression

Optimization of Transcranial Magnetic Stimulation (TMS) for Depression

Sponsors

Lead Sponsor: Medical University of South Carolina

Collaborator: National Institute of Mental Health (NIMH)

Source Medical University of South Carolina
Brief Summary

This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.

Detailed Description

Major depression is a type of depression that can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Because people often develop resistances to medications used to treat depression, new treatments are needed. Decreased electrical activity in the prefrontal region of the brain has been linked to some symptoms of depression. Repetitive transcranial magnetic stimulation (rTMS) can be used to influence the brain's electrical activity. This procedure entails attaching electrodes to the head and using a device to pass magnetic energy through coils and into the brain. rTMS has been shown to have antidepressant effects in depressed individuals. However, optimal levels of intensity and treatment duration have yet to be determined. This study will assess the safety and effectiveness of rTMS on the prefrontal region of the brain in depressed adults with moderate treatment resistance.

The treatment phase of this double-blind study will last a minimum of 32 weeks and will consist of 3 phases. In Phase I, participants will be randomly assigned to receive either rTMS or sham stimulation. The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. In Phase II, participants who were unresponsive to Phase I treatment will receive daily rTMS at a lower dose for 3 weeks. Participants who show signs of improvement, but have not achieved remission, may continue Phase II for 4 additional weeks. Baseline magnetic resonance images will be used to determine the optimal stimulus intensity by adjusting for individual differences in cortical to skull distances. Phase III participants will be only those who achieved remission in the first 2 phases. These participants will receive antidepressant medication treatment daily for six months. Participants' functional status and symptoms of depression will be measured using self-report scales and video-recorded interviews at study start date and at the end of each treatment phase.

Overall Status Completed
Start Date February 2005
Completion Date May 2009
Primary Completion Date April 2009
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Depression Remission, as Measured by the Hamilton Rating Scale for Depression Measured at the end of Phases 1, 2, and 3
Enrollment 190
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Prefrontal rTMS

Description: Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.

Intervention Type: Drug

Intervention Name: Antidepressant Regimen

Description: Particpants who acheive remission with rTMS may start antidepressant medication in phase III.

Arm Group Label: Open label antidepressant regimen

Other Name: medication

Intervention Type: Procedure

Intervention Name: Sham Stimulation

Description: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.

Arm Group Label: Sham rTMS phase 1

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosis of major depression with a current episode

- Hamilton Rating Scale for Depression score higher than 20

- No response or intolerance to antidepressant medication in the current depressive episode

Exclusion Criteria:

- Current use of antidepressants

- Diagnosis of psychosis or anxiety disorder

- Current substance abuse

- Seizures or history of head trauma

Gender: All

Minimum Age: 21 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mark S. George, MD Principal Investigator Medical University of South Carolina
Location
Facility:
Emory University | Atlanta, Georgia, 30329-5102, United States
Columbia University | New York, New York, 10032, United States
Brain Stimulation Laboratory, Medical University of South Carolina | Charleston, South Carolina, 29425, United States
University of Washington | Seattle, Washington, 98104-2499, United States
Location Countries

United States

Verification Date

December 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Active prefrontal rTMS phase1

Type: Experimental

Description: Phase I participants receiving rTMS

Label: Sham rTMS phase 1

Type: Placebo Comparator

Description: Phase I participants receiving sham stimulation

Label: rTMS extension

Type: Experimental

Description: rTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS

Label: Open label antidepressant regimen

Type: Experimental

Description: All patients who met remission who were then transitioned to medications after the TMS trial was completed.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov