Clinical Trial 43166

Los Angeles, CA 90024


Summary:

PCORI has identified treatment-resistant depression as an important research topic. Patients, clinicians, and others want to learn: For patients whose depression has not gotten better after using two types of antidepressants, is it better to add another treatment or switch to a new one?

The research team is assigning patients by chance to receive one of three treatments that the Food and Drug Administration has approved for treatment-resistant depression.

  • For one group of patients, doctors are adding a treatment called repetitive transcranial magnetic stimulation (rTMS) to the antidepressant medicine each patient currently takes. During rTMS, a magnet above a patient’s head painlessly stimulates brain cells to improve depression symptoms. Patients in this treatment group are receiving rTMS five times a week for the first five weeks and twice a week for the next three weeks.
  • For the second group of patients, doctors are adding a second medicine, aripiprazole, to each patient’s current medicine.
  • For the third group of patients, doctors are switching from their current antidepressant medicines to a different medicine, venlafaxine.


INCLUSION CRITERIA

  • Ages 18-80
  • Male or Female
  • Current episode of depression of at least 12 weeks duration
  • Meet criteria for Treatment Resistant Depression (TRD) during the current major depressive episode
  • Have had an inadequate response to at least 2 antidepressants
  • Are currently on an antidepressant for at least 8 weeks
  • Are currently on a stable dose of an antidepressant for at least 4 weeks and
  • Have experienced less than 50% improvement to the current antidepressant


Qualified Participants May Receive:

$100 compensation per completed visit


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.