A Prospective, Double Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H1-Coil deep Transcranial Magnetic Stimulation (TMS) in conjunction with mood stabilizers in Subjects with Bipolar Depression
ID Number 12-0142Principal Investigator(s)
Dan V. Iosifescu
Department(s) or Division(s)
The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS (dTMS) in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications. dTMS is a experimental device and is not approved by the FDA to treat bipolar depression, but the FDA has decided that dTMS is safe to be used in clinical trials.
Individuals may be eligible for this study if they are between ages of 22 and 68 years old and have diagnosis of Bipolar disorder (currently depressed), and taking mood stabilizing medication.
Participation in this research study includes 2 screening visits, daily study treatment visits for 4 weeks with additional study treatments and follow-up visits for three more weeks.
Recruiting Patients: Yes