Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01403441
Status:
TERMINATED
Last Update Posted:
2017-09-05
First Post:
2011-07-25
Brief Title:
Radiosurgical Neuromodulation for Refractory Depression
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Radiosurgical Neuromodulation for Refractory Depression
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Potential AE
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to evaluate the safety and effectiveness of an investigational procedure for treating people with treatment resistant bipolar depression TRD Precise dose delivery of radiation to the predetermined targets in the brain will be accomplished with known Cyberknife stereotactic 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 stereotactic 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
Detailed Description:
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 andor 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 andor 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
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 andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| eprotocol 10186 | None | None | None |