Magnetic Brain Stimulation for the Treatment of Adult Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Prefrontal rTMS; Antidepressant Regimen; Sham Stimulation
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): 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.; Particpants who acheive remission with rTMS may start antidepressant medication in phase III.; The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.
Other intervention name(s): TMS; rTMS; medication
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electric Stimulation; Magnetic Stimulation; Prefrontal Cortex; Brain