Radiosurgical Neuromodulation for Refractory Depression

NCT01403441 | Terminated Results DMC

• 2 other identifiers: SU-12012010-7249eprotocol 10186
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Refractory Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Event

  An event that required hospitalization due to an unanticipated worsening of the subjects bipolar disorder.

  Baseline and 12 months.

Secondary Outcomes (3)

• Hamilton Depression Rating Scale (HDRS) - 17 Item

  Baseline and 12 months

• Clinical Global Impression - Severity (CGI-S) at Baseline and 12 Months

  Baseline and 12 months

• Delis-Kaplan Executive Function System (D-KEFS) Composite Score

  Baseline and 12 months

Study Arms (1)

Radiosurgical Neuromodulation

EXPERIMENTAL

Bilateral Radiosurgical Neuromodulation using the Cyberknife

Device: Radiosurgical Neuromodulation using the Cyberknife

Interventions

Radiosurgical Neuromodulation using the Cyberknife DEVICE

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).

Radiosurgical Neuromodulation

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Hugh Brent Solvason
• Organization: Stanford University

solvason@stanford.edu

650 776 4793

Study Officials

• Hugh Brent Solvason

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Precision radiotherapy is delivered on Day 1 using the Cyberknife System to Brodmann area cingulate 25.

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 5, 2017
• Results First Posted: September 5, 2017

Record last verified: 2017-08

Locations

US (1)