Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression
A Prospective Double Blind Randomized Controlled Trial To Explore The Tolerability, Safety And Efficacy Of The H1-Coil Deep Transcranial Magnetic Stimulation (TMS) In Subjects With Bipolar Depression
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
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 ≥
- 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
- 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
- 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
- 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
- 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