Magnetic Brain Stimulation for the Treatment of Adult Depression

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.

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