Magnetic Brain Stimulation for the Treatment of Adult Depression

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Depression	Procedure: Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS); Drug: Antidepressant Regimen; Procedure: Sham Stimulation; Procedure: Lower Dose rTMS	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	199 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Optimization of TMS for Depression
Study Start Date :	February 2005
Actual Primary Completion Date :	April 2009
Actual Study Completion Date :	May 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Phase I participants receiving rTMS	Procedure: Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS); 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.; Other Names: TMS; rTMS
Placebo Comparator: 2; Phase I participants receiving sham stimulation	Procedure: 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.
Experimental: 3; Phase II participants	Procedure: Lower Dose rTMS; Participants who are unresponsive to Phase I treatment with rTMS will continue a lower dose of rTMS for an additional 3 to 7 weeks in Phase II.
Experimental: 4; Phase III participants	Drug: Antidepressant Regimen; Particpants who acheive remission with rTMS may start antidepressant medication in phase III.

Outcome Measures

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Primary Outcome Measures :

1. Depression remission, as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at the end of Phases 1, 2, and 3 ]

Secondary Outcome Measures :

1. Change in depression symptoms, motor threshold, and hearing [ Time Frame: Measured at the end of Phases 1, 2, and 3 ]
2. Safety and side effect data [ Time Frame: Measured daily throughout out treatment ]
3. Neuropsychological changes [ Time Frame: Measured at the end of Phases 1 and 2 ]
4. Quality of life [ Time Frame: Measured weekly throughout treatment ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329-5102
United States, New York
Columbia University
New York, New York, United States, 10032
United States, South Carolina
Brain Stimulation Laboratory, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
University of Washington
Seattle, Washington, United States, 98104-2499

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Mark S. George, MD	Medical University of South Carolina

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Borckardt JJ, Nahas ZH, Teal J, Lisanby SH, McDonald WM, Avery D, Durkalski V, Pavlicova M, Long JM, Sackeim HA, George MS. The painfulness of active, but not sham, transcranial magnetic stimulation decreases rapidly over time: results from the double-blind phase of the OPT-TMS Trial. Brain Stimul. 2013 Nov;6(6):925-8. doi: 10.1016/j.brs.2013.04.009. Epub 2013 May 21.

George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.

Responsible Party:	Mark George, Distinguished Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00149838 History of Changes
Other Study ID Numbers:	R01MH069887 ( U.S. NIH Grant/Contract ); DATR A5-ETMA
First Posted:	September 8, 2005
Last Update Posted:	April 30, 2012
Last Verified:	April 2012

Keywords provided by Mark George, Medical University of South Carolina:

Electric Stimulation; Magnetic Stimulation; Prefrontal Cortex; Brain

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders	Mental Disorders; Antidepressive Agents; Psychotropic Drugs