Radiosurgical Neuromodulation for Refractory Depression
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|ClinicalTrials.gov Identifier: NCT01403441|
Recruitment Status : Terminated (Potential AE)
First Posted : July 27, 2011
Results First Posted : September 5, 2017
Last Update Posted : September 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Device: Radiosurgical Neuromodulation using the Cyberknife||Not Applicable|
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 6 megavolt (MV) 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 electroconvulsive therapy (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 Delas-Kaplan Executive Function System (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 radiomodulation to the cingulate cortex target Cg25 in patients with refractory bipolar depression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Precision radiotherapy is delivered on Day 1 using the Cyberknife System to Brodmann area cingulate 25.|
|Masking:||None (Open Label)|
|Official Title:||Radiosurgical Neuromodulation for Refractory Depression|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Experimental: Radiosurgical Neuromodulation
Bilateral Radiosurgical Neuromodulation using the Cyberknife
Device: Radiosurgical Neuromodulation using the Cyberknife
our team has selected 60 Gray (Gy) as the dose to the target margin to be used for radiosurgical neuromodulation in patients with intractable bipolar disorder; the target being the anterior cingulate (Cg) that correlates with Brodmann area 25 (Cg25).
- Serious Adverse Event [ Time Frame: Baseline and 12 months. ]An event that required hospitalization due to an unanticipated worsening of the subjects bipolar disorder.
- Hamilton Depression Rating Scale (HDRS) - 17 Item [ Time Frame: Baseline and 12 months ]The HDRS is a rating scale measures the severity of depressive symptoms. The scale consists of 17 symptoms with severity anchors that are scored from 0 to 4. The maximum score (most severe depression) is 68, the lowest (no depressive symptoms) is 0.
- Clinical Global Impression - Severity (CGI-S) at Baseline and 12 Months [ Time Frame: Baseline and 12 months ]The CGI-S assess the overall severity of depression over the 12 month observation period following Cyberknife System. It is rated from 1 (well or remitted) to 7 (severely ill, among the most depressed).
- Delis-Kaplan Executive Function System (D-KEFS) Composite Score [ Time Frame: Baseline and 12 months ]D-KEFS is a neurocognitive assessment of executive function. The composite score is derived from scores on tests that include Trails A, Color Word Interference, Verbal Fluency, Sorting, WAIS III Digit Span, and CVLT II Long Delay Free Recall. The scores are reported as deviation from a mean of 10, with a standard deviation of 3. A score of 7 is one standard deviation below the mean, while a score of 13 is 1 standard deviation above the mean. Higher numeric outcomes reflect better performance on the test, lower values reflect poorer performance. Results reflect scores at baseline, and 12 month observation period following Cyberknife System
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403441
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Hugh Brent Solvason||Stanford University|