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Magnetic Brain Stimulation for the Treatment of Adult Depression

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Magnetic Brain Stimulation for the Treatment of Adult Depression
Official Title  Optimization of TMS for Depression
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 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 Phase 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
Primary Outcome Measure  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 ]
Secondary Outcome Measure  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 ]
Condition  Depression
Intervention  Procedure: Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS)
Drug: Antidepressant Regimen
Procedure: Sham Stimulation
Procedure: Lower Dose rTMS
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  240
Start Date  February 2005
Completion Date May 2009
Eligibility Criteria 

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
Gender Both
Ages 21 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Mark S. George, MD     843-876-5142     georgem@musc.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00149838
Organization ID R01 MH69887
Secondary IDs †† DATR A5-ETMA
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Mark S. George, MD     Medical University of South Carolina    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date January 2008
First Received Date  September 6, 2005
Last Updated Date January 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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