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
  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
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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 Measures:
  • 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:
  • TMS
  • rTMS
Placebo Comparator: 2
Phase I participants receiving sham stimulation
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.
Experimental: 3
Phase II participants
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: 4
Phase III participants
Drug: Antidepressant Regimen
Particpants who acheive remission with rTMS may start antidepressant medication in phase III.

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149838

Locations
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
Sponsors and Collaborators
Investigators
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
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014