Bipolar Disorder Clinical Trial
Official title:
Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder: Pilot Trial
Bipolar Disorder (BD) is among the most comon and challenging conditions in psychiatry. Although episodes of mania and hypomania define the different types of the disorder, the clinical picture is one dominated by depressed mood and agitation. The mainstay of BD treatment has thus far been pharmacologic, but many patients remain severely disabled by their condition, despite the best available medical treatment. The successful use of deep brain stimulation (DBS) in movement disorders, and its promising results in major depressive disorder (MDD), has led researchers to consider its use in highly selected refractory cases of BD. Evidence form the imaging and circuitry literature suggests that similar underlying dyfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key structures, can lead to an amelioration of symptoms and mood stabilization. Here, we propose a phase I clinical trial to evaluate the safety of DBS in BD.
Bipolar disorder (BD) is a complex and disabling disorder that is among the most challenging
diagnoses in psychiatry. Although episodes of mania and hypomania define the different types
of the disorder, the clinical picture is one dominated by depressed mood and agitation.
Detection and diagnosis of BD remains a challenge, as most individuals with BD spend many
years misdiagnosed as major depression disorder (MDD), often leading to under-treatment or
inappropriate treatment. Several studies have attempted to elucidate features of a major
depressive episode that indicate an underlying diagnosis of MDD versus bipolar depression.
During the last fifteen years, there have been significant advances in our understanding of
the pathophysiology and relevant neuroanatomy and neurocircuitry underlying mood disorders.
Much of that progress has been made as a result of technological advances in neuroimaging,
both structural and functional.
Deep Brain Stimulation is a neurosurgical tool has been used for over twenty-five years to
treat various neurologic and psychiatric conditions. DBS is believed to work by using small
amounts of electricity to disrupt the activity of brain structures that produce troublesome
symptoms. In the case of Parkinson's disease, DBS is successful in treating the tremor and
general slowing that are major parts of that condition. DBS has also been used in psychiatric
patients, both as part of treatment, in cases of Obsessive-Compulsive Disorder (OCD), and
research, in cases of Depression. The successful use of deep brain stimulation (DBS) in
movement disorders, and its promising results in major depressive disorder (MDD), has led
researchers to consider its use in highly selected refractory cases of BD. Evidence form the
imaging and circuitry literature suggests that similar underlying dysfunctional anatomic
structures subserve both MDD and BD, indicating that modulation of key structures, can lead
to an amelioration of symptoms and mood stabilization.
Our primary objective is to establish the safety of deep brain stimulation in a patient
population with treatment refractory bipolar disorder.
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