Clinical Trial for Patients Diagnosed with Bipolar Depression

We are currently enrolling patients in a clinical research study to evaluate the efficacy and safety of an investigational device known as the Brainsway H-Coil. Subjects must currently be diagnosed with bipolar depression, taking mood stabilizers, and have been previously unsuccessfully treated with antidepressant medications. The study is designed to last for a period of 8 weeks, including a 3 week taper down period off medications and 5 weeks of treatment. Mood and mental status will be closely monitored with psychological scales and assessments throughout the trial duration.

 

The Importance of Finding a New, Effective Treatment

For patients with bipolar depression, experiencing symptom relief is often difficult. For one, the ups and downs make it especially challenging for doctors to identify an effective treatment strategy to manage symptoms. Specifically, there are currently only 2 FDA approved pharmacotherapies to treat depression in patients with bipolar depression, including 1 medication (Quetiapine) and 1 medication combination (Olanzapine with Fluoxetine). The most effective nonpharmacologic treatment option is electroconvulsive therapy (ECT); however, patients are hesitant to try this due to fear of experiencing memory loss and the negative stigma of “shock therapy.” Thus, there is a need for a more effective treatment option for the estimated 5.7 million adults who suffer from the disorder. Repetitive transcranial magnetic stimulation (TMS) has currently been FDA approved for patients suffering from unipolar depression, with the Brainsway deep TMS device being one of them. In the current FDA clinical trial, the effectiveness of this deep TMS device in treating depression in patients with bipolar disorder is being investigated. The trial is expected to run through 2014.

Figure 1. A sketch of the H1-Coil at the treatment position over the frontal cortex.

 

Figure 2. The colored field map shows activation of the prefrontal cortex up to a depth of 3 cm below the skull.

 

Inclusion Criteria:*

  • Patients suffering from an episode of bipolar depression
  • Men and Women Ages 22-68 years
  • Taking mood stabilizing medication (e.g., Lithium, Lamictal, Tegretol, Topamax, etc.) at a therapeutic dose or atypical antipsychotic medication which was prescribed as mood stabilizers by their treating physician, except for Leponex (Clozapine)

 

Exclusion Criteria:*

  • Patients diagnosed as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to borderline personality disorder. Subjects suffering from any other Severe Personality Disorder will also be excluded.
  • Present suicidal risk
  • History of epilepsy or seizure or history of such in first degree relatives
  • History of any metal in the head (outside the mouth)
  • Significant hearing loss
  • Individuals with a significant neurological disorder or insult including, but not limited to:
    • Cerebral aneurysm
    • Dementia
    • Parkinson’s disease
    • Huntington’s chorea
    • Multiple sclerosis
  • Current history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine)
  • Participants who suffer from an unstable physical disease such as high blood pressure or acute, unstable cardiac disease
  • Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the baseline visit
  • Women who are breast-feeding
  • Known or suspected pregnancy

 

*The criteria listed above are not exhaustive. For additional information regarding this trial or to see if you qualify, please email Dr. Aron Tendler aron.tendler@gmail.com, or call 561-333-8884.