double blind randomized controlled, h1 coil in subjects with bipolar depression

Conditions: Bipolar Depression

Summary: the purpose of the study is to explore the efficacy and safety of h1-coil deep brain rtms in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications


Eligibility criteria:
inclusion criteria:• outpatients * diagnosed by two senior psychiatrists as suffering from bipolar depression (bp1, bp2) episode according to dsm iv using the structured clinical interview for dsm-4 (scid), with additional requirement of duration for the current episode ≥ 4 weeks and cgi ≥ 4. * rating on ham-d (17 items) \>20 and item 1 ≥2 at the screening visit. * age: 18-65 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) on an acceptable range of dosage according to recent blood examination or antipsychotic medication as mood stabilizers prescribed by their treating physician * according to the treating physician the patient is compliant in taking the mood-stabilizing medication. * medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 2 antidepressant drug trials of adequate dose and duration in the current episode or previous episodes defined as a minimum level of 3 on the athf per antidepressant drug-trial. * patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to 3 or more anti-depressant medications in the current or a previous episodes. * if currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents. * able to tolerate psychotropic medication washout and no psychotropics during the h-coil deep brain rtms other than benzodiazepine at equivalent dose of up to 3 mg lorazepam every day. * right hand dominance. exclusion criteria:• diagnosis as suffering from other diagnosis on axis 1 (like: schizophrenia, geriatric depression). * diagnosis as suffering from severe borderline personality disorder or hospitalized due to exacerbation related to of borderline personality disorder. * substantial suicidal risk as judged by the treating psychiatrist. * attempted suicide in the past year. * patients with a bipolar cycle of less than 30 days. * history of epilepsy or seizure in first degree relatives. * history of head injury. * history of any metal in the head (outside the mouth). * known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps. * history of frequent or severe headaches. * history of migraine. * history of hearing loss. * known history of cochlear implants * history of substance abuse within the past 6 months (except nicotine and caffeine) or alcoholism * pregnancy or not using a reliable method of birth control. * unstable systemic and metabolic disorders. * unstable neurological or medical disease * inadequate communication with the patient. * under custodial care. * participation in current clinical study or clinical study within 30 days prior to this study.

Keywords: bipolar depression prefrontal cortex antidepressant response