Radiosurgical Neuromodulation for Refractory Depression

Stopped early · Not applicable

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT01403441

Run by

Stanford University

People needed

3

Starts

2010-07-01

Expected to finish

2013-01-01

Last updated by the study team

2017-09-05

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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