Status:
TERMINATED
Radiosurgical Neuromodulation for Refractory Depression
Lead Sponsor:
Stanford University
Conditions:
Bipolar Disorder
Eligibility:
All Genders
22-65 years
Phase:
NA
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 radiatio...
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 ove...
Eligibility Criteria
Inclusion
- 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 the Diagnostic and Statistical Manual - Text Revision (DSM IV-TR) criteria
- The current major depressive episode has been for at least one year
- Hamilton Depression Rating Scale (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 positron emission tomography (PET) imaging
- Signed consent form for participation in the study
Exclusion
- Patients who meet the following criteria will be excluded from participation in this research study:
- Rapid cycling bipolar illness
- History of schizophrenia, schizoaffective disorder, or psychosis
- Severe suicidal thoughts that may put the subject at risk of either an attempted suicide or completed suicide for the duration of the trial, as determined by the investigator at the time of enrollment
- Current substance abuse or in the process of withdrawal from mind-altering substances including alcohol, stimulants, or sedatives
- Undisclosed or undiagnosed unstable medical or neurologic illness including stroke, significant brain malformation, brain mass
- Previous whole-brain radiation
- Brain-implanted devices such as deep brain stimulation leads, aneurysm clips
- A history of seizure disorder
- History of moderate to severe brain injury
- Current treatment with either metronidazole or cisplatinum and an inability to discontinue prior to RSN
- Pregnancy or breast feeding
- Unstable medical illness
- Current participation in another investigational trial or participation within 30 days of enrollment
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01403441
Start Date
July 1 2010
End Date
January 1 2013
Last Update
September 5 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305