Radiosurgical Neuromodulation for Refractory Depression
This study is designed to evaluate the safety and effectiveness of an investigational procedure for treating people with treatment resistant bipolar depression. Precise dose delivery of radiation to the predetermined targets in the brain will be accomplished with known Cyberknife stereotactive radiosurgery methods.. This technology is considered to be noninvasive (does not physically invade your body). We will be studying if the Cyberknife influences the sensitivity of certain nerves of your brain. Although many clinical treatments for psychiatric conditions have been done using stereotactive radiosurgery, the present study is experimental, because we are seeking to use more moderate doses of radiation that are intended not to destroy any brain cells, but to normalize or modulate their function.
- device : Radiosurgical Neuromodulation using the Cyberknife
Phase: Phase 2
Ages Eligible For Study:
In order to be eligible to participate, all patients must meet the following criteria: - Men and women 22-65 years of age - Primary diagnosis of bipolar depression, as per DSM IV-TR criteria - The current major depressive episode has been for at least one year - HDRS-24 item greater than or equal to 20 - Negative urine pregnancy in female subjects - No current psychotic symptoms - No comorbid post traumatic stress disorder, the inclusion of subjects with other psychiatric comorbidity will be determined by the investigator prior to enrollment - No personality disorder that in the opinion of the investigator may compromise the subjects ability to participate and be compliant with the elements and procedures of the study - No substance abuse of dependence in the last 6 months - A negative urine drug screen - On a stable dose of their current medication regimen for four weeks - Treatment resistance: A history of failure to show clinical improvement after at least four different medication trials of adequate duration and dose and one course of ECT. A course of ECT is not mandatory for those who have declined the procedure due to stigma, patient preference, or intolerance. One course of ECT is defined as receiving six acute treatments. (Note: the Antidepressant Treatment History Form (ATHF) does not apply to bipolar depression where mood stabilizers are the treatments of choice in the first three steps in an algorithm to treat bipolar depression) - No available reasonable treatment options at the time of enrollment - Competent to understand the risks and potential benefits of the study - Able to provide written informed consent for the full screening phase, as well as the treatment period of the protocol, including the baseline MRI, CT and PET imaging - Signed consent form for participation in the study