Magnetic Brain Stimulation for the Treatment of Adult Depression
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Purpose
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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Optimization of TMS for Depression |
- Depression remission, as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at the end of Phases 1, 2, and 3 ] [ Designated as safety issue: No ]
- Change in depression symptoms, motor threshold, and hearing [ Time Frame: Measured at the end of Phases 1, 2, and 3 ] [ Designated as safety issue: Yes ]
- Safety and side effect data [ Time Frame: Measured daily throughout out treatment ] [ Designated as safety issue: Yes ]
- Neuropsychological changes [ Time Frame: Measured at the end of Phases 1 and 2 ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: Measured weekly throughout treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 199 |
| Study Start Date: | February 2005 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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Placebo Comparator: 2
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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Experimental: 3
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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Experimental: 4
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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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.
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00149838
| 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 | |
| Principal Investigator: | Mark S. George, MD | Medical University of South Carolina |
More Information
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mark George, Distinguished Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00149838 History of Changes |
| Other Study ID Numbers: | R01 MH069887, DATR A5-ETMA |
| Study First Received: | September 6, 2005 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Electric Stimulation Magnetic Stimulation Prefrontal Cortex Brain |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mental Disorders Mood Disorders |
Antidepressive Agents Central Nervous System Agents Pharmacologic Actions Psychotropic Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015