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Radiosurgical Neuromodulation for Refractory Depression

This study has been terminated.
(Potential AE)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01403441
First Posted: July 27, 2011
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hugh Brent Solvason, Stanford University
Results First Submitted: October 10, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Intervention: Device: Radiosurgical Neuromodulation using the Cyberknife

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started in August 2010, through July 2012. Subjects recruited from outpatient referrals. 5 subjects were screened, 3 enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No group assignment, open label study.

Reporting Groups
  Description
Open Treatment Study All three subjects had Cyberknife treatment targeting the subgenual cingulate cortex, and then followed for 12 months observation and assessments of depression severity.

Participant Flow:   Overall Study
    Open Treatment Study
STARTED   3 
COMPLETED   3 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treatment Resistant Depression

Reporting Groups
  Description
Open Treatment Study Open treatment with Cyberknife System targeting brain area cingulate 25.

Baseline Measures
   Open Treatment Study 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.3  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  33.3% 
Male      2  66.7% 
Region of Enrollment 
[Units: Participants]
 
United States   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serious Adverse Event   [ Time Frame: Baseline and 12 months. ]

2.  Secondary:   Hamilton Depression Rating Scale (HDRS) - 17 Item   [ Time Frame: Baseline and 12 months ]

3.  Secondary:   Clinical Global Impression - Severity (CGI-S) at Baseline and 12 Months   [ Time Frame: Baseline and 12 months ]

4.  Secondary:   Delis-Kaplan Executive Function System (D-KEFS) Composite Score   [ Time Frame: Baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Hugh Brent Solvason
Organization: Stanford University
phone: 650 776 4793
e-mail: solvason@stanford.edu



Responsible Party: Hugh Brent Solvason, Stanford University
ClinicalTrials.gov Identifier: NCT01403441     History of Changes
Other Study ID Numbers: SU-12012010-7249
eprotocol 10186
First Submitted: July 25, 2011
First Posted: July 27, 2011
Results First Submitted: October 10, 2016
Results First Posted: September 4, 2017
Last Update Posted: September 4, 2017