rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II (rTMS)

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Type II, Depression, rTMS Read More

Inclusion Criteria:

• Male and female outpatients aged 18-55 years old
• Meet DSM-IV criteria for Bipolar Affective Disorder Type II, depressed phase without psychosis as determined by Structured Clinical Interview for DSM-IV
• A MADRS ≥ 15 at Initial Visit, and at Prior to TMS Evaluation
• A Young Mania Rating Scale < 12 at Initial Visit and at Prior to TMS Evaluation
• Duration of current episode of depression >2 months but ≤ 1 year of unsuccessful treatment
• On stable medication and/or psychotherapy for 1 month and clinically appropriate to maintain for duration of trial
• Cognitively intact (Folstein MMSE score >24).
• Clinically competent to give informed written consent

Exclusion Criteria:

• History of epilepsy or seizure disorder, mass brain lesions, cerebrovascular accident, metal in the skull, a history of major head trauma, or any neurologic condition likely to increase risk of rTMS.
• Suicidal risk that precludes safe participation defined as score of 5 or 6 on MADRS item 10 Suicidal Thoughts or clinical impression that the subject is at significant risk for suicide.
• History of any DSM-IV Axis I diagnosis other than Bipolar Affective Disorder Type II, depressed phase, simple phobia and generalized anxiety disorder (GAD) in the last year
• Lifetime history of schizophrenia, schizoaffective, or other psychotic disorder, bipolar disorder type I, dementia, dissociative disorders, and sexual and gender identity disorder
• Personality disorder that makes participation in the trial difficult
• Greater than or equal to 8 episodes of mood disturbance in the previous 12 months
• Greater than 4 unsuccessful treatments in current episode
• History of Substance Abuse or Dependence (DSM-IV) in the last year except nicotine and caffeine
• Positive urine drug test during screening
• Taking any medication that significantly lowers the seizure threshold (e.g. lithium, stimulants, bupropion, TCAs, antipsychotics, theophylline, etc.)
• Unstable medical conditions that precludes safe participation in rTMS treatment trial
• Known or suspected pregnancy
• Women of child-bearing potential not using medically accepted form of contraception when engaged in sexual intercourse
• Any metal or device implants that would increase risk of rTMS
• Unable to determine the motor threshold in the subject
• History of Vagus Nerve Stimulation
• Currently in another investigational study
• Prior electroconvulsive therapy failure