A Prospective , Double-Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Conjunction with Mood Stabilizers in Subject with Bipolar Depression
This is a prospective, 8-week, double blind, randomized, controlled, multi-center trial in outpatients recruited in both academic and private research centers. The proposed study will compare two groups of patients with bipolar depression (BP1 and BP2). One group will be assigned to the DTMS treatment (H1 coil), and the other group will be assigned to the sham treatment (sham coil). The patients and amp;apos; clinical condition will be assessed before, during and after the treatment in order to evaluate their response to the H1-coil rTMS treatment. Both groups will be stratifed according to symptom severity. The treatment group will receive 4 weeks of daily DTMS treatments with the H1 coil followed by 3 treatments in week 5 and 1 treatment in week 6, for a total of 24 treatment sessions and 1980 magnetic stimulations per session. The control group will receive the same treatments with a sham coil, for a total of 24 treatment sessions, as well. Each DTMS session will consist of 55 trains. The duration of each train will be two seconds and the inter-train interval will be 20 seconds.
•Diagnosed as suffering from an episode of bipolar depression (BP1 or BP2) according to DSM IV, with the additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4.
•Rating on HDRS (21 items) >20 and item 1 ≥ 2 at the screening visit.
•Age: 22-68 years.
•Gave informed consent for participation in the study.
•Negative answers on safety screening questionnaire for transcranial magnetic stimulation
•Taking mood stabilizing medication (e.g., Lithium, Lamictal, Tegretol, etc.) at a therapeutic dose or atypical antipsychotic medication which was prescribed as mood stabilizers by their treating physician, except for Leponex (Clozapine). According to the treating physician the patient is compliant with taking the mood-stabilizing medication.
•If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
•Able to tolerate psychotropic and stimulant medication washout and no new psychotropics or stimulants during the H-coil deep brain rTMS, other than benzodiazepines at an equivalent dose of up to 3 mg lorazepam every day and mood stabilizing medications.