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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00149838 |
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 | Intervention | Phase |
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Depression |
Procedure: Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) Drug: Antidepressant Regimen Procedure: Sham Stimulation Procedure: Lower Dose rTMS |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Optimization of TMS for Depression |
Estimated Enrollment: | 240 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Phase I participants receiving rTMS
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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.
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2: Placebo Comparator
Phase I participants receiving sham stimulation
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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.
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3: Experimental
Phase II participants
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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.
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4: Experimental
Phase III participants
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Drug: Antidepressant Regimen
Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
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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.
Ages Eligible for Study: | 21 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark S. George, MD | 843-876-5142 | georgem@musc.edu |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30329-5102 | |
Contact: Sinead Quinn 404-728-6957 squinn@emory.edu | |
Principal Investigator: William McDonald, MD | |
United States, New York | |
Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Seth Disner 212-543-5767 disners@pi.cpmc.columbia.edu | |
Principal Investigator: Sarah H. Lisanby, MD | |
United States, South Carolina | |
Brain Stimulation Laboratory, Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Berry Anderson, RN 843-792-9476 andersob@musc.edu | |
Principal Investigator: Mark S. George, MD | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98104-2499 | |
Contact: Chandra Wajdik 206-744-2436 cwajdik@u.washington.edu | |
Principal Investigator: David Avery, MD |
Principal Investigator: | Mark S. George, MD | Medical University of South Carolina |
Responsible Party: | MUSC ( Mark George, MD ) |
Study ID Numbers: | R01 MH69887, DATR A5-ETMA |
Study First Received: | September 6, 2005 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00149838 |
Health Authority: | United States: Federal Government |
Electric Stimulation Magnetic Stimulation Prefrontal Cortex Brain |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |