Radiosurgical Neuromodulation for Refractory Depression

Not Recruiting

Trial ID: NCT01403441


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.

Official Title

Radiosurgical Neuromodulation for Refractory Depression

Stanford Investigator(s)

Hugh Brent Solvason PhD MD
Hugh Brent Solvason PhD MD

Clinical Professor, Psychiatry and Behavioral Sciences

Charles DeBattista
Charles DeBattista

Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology - Adult)


Inclusion Criteria:

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 Criteria:

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


device: Radiosurgical Neuromodulation using the Cyberknife

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jessica Hawkins