Treatment of Bipolar Depression With H1-Coil Deep Brain rTMS: Clinical-Cognitive and Safety Evaluation (rTMSH1Coil)

This is an interventional treatment trial for Bipolar Depression focused on measuring Deep Brain Transcranial Magnetic Stimulation;, H1-Coil deep brain rTMS;, H1-Coil;, Bipolar Depression;, Cognition. Read More

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.
• First Stimulation threshold: intensity ≤ 70% of the threshold engine.
• Rating on HAM-D (17 items) >18 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.
• Participants who suffer from an unstable physical disease such as high blood pressure or acute, unstable cardiac disease
• Use of fluoxetine within 6 weeks of the baseline visit
• Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the baseline visit
• Current use of antidepressant medications during the course of the trial.
• Current use of Leponex (Clozapine).
• Previous treatment with TMS
• Women who are breast-feeding
• Known or suspected pregnancy
• Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.