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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Radiosurgical Neuromodulation for Refractory Depression|
- adverse event [ Time Frame: Over the 12 month study period ] [ Designated as safety issue: Yes ]
- Hamilton Depression Rating Scale [ Time Frame: Over the 12 month study period ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Main objective: To determine the safety of Radiosurgical Neuromodulation (RSN) for Refractory Depression using X-rays in a population of subjects with severe treatment resistant bipolar depression over a 12-month observational period post treatment. While almost any radiosurgical device could be used, the research team has extensive experience with the Accuray CyberKnife System, K011024, and it will be used for planning and delivery of the 6MV X-ray treatment for this study.
Participation will be dependent upon subjects having a diagnosis of bipolar depression and meeting criteria for treatment resistance. Treatment resistance will be defined as a failure to show clinical improvement after at least four different medication trials and/or one course of ECT during the current episode. A medication trial is defined as an adequate dose and duration of one of four classes of psychoactive medications: lithium, anticonvulsant mood stabilizers, atypical antipsychotic mood stabilizers, and/or antidepressant medications. One course of ECT is defined as receiving six acute treatments. The study will include subjects who have failed ECT, or have had intolerable side effects to ECT, or elected not to receive such treatment due to stigma, or concern over possible side effects of the ECT treatment itself. The subjects enrolled will have exhausted all reasonable treatment strategies, and currently have no other reasonable or viable treatment options for their illness.
Secondary objective: To examine clinical outcome initially over 3 months, then with follow up at 6, 9 and 12 months. Depression will be assessed using the Hamilton Depression Rating Scale (HDRS) 24 item, while manic symptoms will be measured by using the Young Mania Rating Scale (YMRS), and the Clinical Global Impression of Severity of illness (CGI-S), and Improvement (CGI-I). A battery of neuropsychological tests will be administered as well, assessing memory with the California Verbal Learning Task (CVLT), prefrontal function using a DKEFS battery including the DKEFS Sorting task, DKEFS Trails task, DKEFS color-word interference task, and the DKEFS verbal fluency task. In addition, the investigators will request information regarding any possible adverse events that occur during this trial.
The intended use for the CyberKnife System, the radiosurgical device being used in this research study, is to administer radiomodulaton to the cingulate cortex target Cg25 in patients with refractory bipolar depression.
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Hugh Brent Solvason||Stanford University|