Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149838
Status:
COMPLETED
Last Update Posted:
2018-12-28
First Post:
2005-09-06
Brief Title:
Magnetic Brain Stimulation for the Treatment of Adult Depression
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Optimization of Transcranial Magnetic Stimulation TMS for Depression
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 brains 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH069887 | NIH | None | None |
| DATR A5-ETMA | OTHER | NIH | httpsreporternihgovquickSearchR01MH069887 |