Magnetic Brain Stimulation for the Treatment of Adult Depression

Depression Clinical Trial

Official title:

Optimization of Transcranial Magnetic Stimulation (TMS) for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149838
• Other study ID #: R01MH069887
• Secondary ID: R01MH069887DATR
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2005
• Est. completion date: May 2009

Study information

• Verified date: December 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Brain Stimulation Laboratory, Medical University of South Carolina	Charleston	South Carolina
United States	Columbia University	New York	New York
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Remission, as Measured by the Hamilton Rating Scale for Depression	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	Measured at the end of Phases 1, 2, and 3