Magnetic Brain Stimulation for the Treatment of Adult Depression
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|ClinicalTrials.gov Identifier: NCT00149838|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 30, 2012
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Optimization of TMS for Depression|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
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.
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.
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.
Phase III participants
Drug: Antidepressant Regimen
Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
- Depression remission, as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at the end of Phases 1, 2, and 3 ]
- Change in depression symptoms, motor threshold, and hearing [ Time Frame: Measured at the end of Phases 1, 2, and 3 ]
- Safety and side effect data [ Time Frame: Measured daily throughout out treatment ]
- Neuropsychological changes [ Time Frame: Measured at the end of Phases 1 and 2 ]
- Quality of life [ Time Frame: Measured weekly throughout treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149838
|United States, Georgia|
|Atlanta, Georgia, United States, 30329-5102|
|United States, New York|
|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|
|Principal Investigator:||Mark S. George, MD||Medical University of South Carolina|