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Magnetic Brain Stimulation for the Treatment of Adult Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark George, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00149838
First received: September 6, 2005
Last updated: April 26, 2012
Last verified: April 2012

September 6, 2005
April 26, 2012
February 2005
April 2009   (final data collection date for 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 ]
Depression remission, as measured by the Hamilton Rating Scale for Depression, at the end of Phases 1, 2, and 3
Complete list of historical versions of study NCT00149838 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in depression symptoms
  • safety and side effect data
  • neuropsychological changes
  • quality of life
Not Provided
Not Provided
 
Magnetic Brain Stimulation for the Treatment of Adult Depression
Optimization of TMS for Depression

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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:
    • TMS
    • rTMS
  • Drug: Antidepressant Regimen
    Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
  • 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.
  • 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.
  • Experimental: 1
    Phase I participants receiving rTMS
    Intervention: Procedure: Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS)
  • Placebo Comparator: 2
    Phase I participants receiving sham stimulation
    Intervention: Procedure: Sham Stimulation
  • Experimental: 3
    Phase II participants
    Intervention: Procedure: Lower Dose rTMS
  • Experimental: 4
    Phase III participants
    Intervention: Drug: Antidepressant Regimen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149838
R01 MH069887, DATR A5-ETMA
Yes
Mark George, Medical University of South Carolina
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Mark S. George, MD Medical University of South Carolina
National Institute of Mental Health (NIMH)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP