Magnetic Brain Stimulation for the Treatment of Adult Depression
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| ClinicalTrials.gov Identifier: NCT00149838 |
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Recruitment Status :
Completed
First Posted : September 8, 2005
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression | Procedure: Prefrontal rTMS Drug: Antidepressant Regimen Procedure: Sham Stimulation | 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 : | 190 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Optimization of Transcranial Magnetic Stimulation (TMS) for Depression |
| Study Start Date : | February 2005 |
| Actual Primary Completion Date : | April 2009 |
| Actual Study Completion Date : | May 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Active prefrontal rTMS phase1
Phase I participants receiving rTMS
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Procedure: Prefrontal 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: Sham rTMS phase 1
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: rTMS extension
rTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS
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Procedure: Prefrontal 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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Experimental: Open label antidepressant regimen
All patients who met remission who were then transitioned to medications after the TMS trial was completed.
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Drug: Antidepressant Regimen
Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
Other Name: medication |
- Depression Remission, as Measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at the end of Phases 1, 2, and 3 ]The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8
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| Ages Eligible for Study: | 21 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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 | |
| 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 |
| Responsible Party: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00149838 |
| Other Study ID Numbers: |
R01MH069887 ( U.S. NIH Grant/Contract ) R01MH069887 ( U.S. NIH Grant/Contract ) DATR A5-ETMA ( Other Identifier: NIH ) |
| First Posted: | September 8, 2005 Key Record Dates |
| Results First Posted: | December 28, 2018 |
| Last Update Posted: | December 28, 2018 |
| Last Verified: | December 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Interested researchers can email the PI, Dr. George, with a request and how they plan to analyze the data. He will then make available a de-identified copy of the data. |
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Electric Stimulation Magnetic Stimulation Prefrontal Cortex Brain |
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Depression Depressive Disorder Behavioral Symptoms Mood Disorders |
Mental Disorders Antidepressive Agents Psychotropic Drugs |