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Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)

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ClinicalTrials.gov Identifier: NCT01898429
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Holtzheimer, Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Treatment Resistant Depression
Depressive Disorder, Treatment-Resistant
Depression, Bipolar
Intervention Device: SCC DBS
Enrollment 5
Recruitment Details Recruitment began in Jan 2012. Participants were enrolled from July 2013 through January 2016. Patients were primarily recruited by clinicaltrials.gov and through information provided to providers.
Pre-assignment Details All participants entered the left unilateral stimulation phase first; all then transitioned to the right side. This decision was made by the unblinded programmer. Patients and raters were still blinded to treatment allocation.
Arm/Group Title Left-sided SCC DBS Right-sided SCC DBS Bilateral SCC DBS
Hide Arm/Group Description

Active Stimulation of the left-sided electrode

SCC DBS: Deep Brain Stimulator

Active stimulation of the right-sided electrode

SCC DBS: Deep Brain Stimulator

12 weeks of bilateral SCC DBS
Period Title: Phase 1
Started 5 0 0
Completed 5 0 0
Not Completed 0 0 0
Period Title: Phase 2
Started 0 5 0
Completed 0 5 0
Not Completed 0 0 0
Period Title: Phase 3
Started 0 0 5
Completed 0 0 5
Not Completed 0 0 0
Arm/Group Title All Participants
Hide Arm/Group Description

Active Stimulation of the left-sided electrode in the first phase (followed by right-sided stimulation in the second phase)

SCC DBS: Deep Brain Stimulator

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
All patients entered the left-sided phase first, then crossed over to the right-sided phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
45  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
5
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
HDRS-17  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 5 participants
22.4  (2.0)
1.Primary Outcome
Title Comparison of 12 Weeks of Left Unilateral DBS vs. 12 Weeks Right Unilateral DBS on Change in 17-item Hamilton Depression Rating Scale (HDRS-17)
Hide Description Baseline HDRS-17 is defined as the average of 4 weekly HDRS-17 in the 4 weeks leading up to surgery. Change in HDRS-17 after 12 weeks of left-sided stimulation (compared to baseline) will be compared to change in HDRS-17 after 12 weeks of right-sided stimulation (compared to baseline). The scale ranges from 0-48 with higher scored indicating more severe depression. A cutoff of 7 or below is considered remission from depression. A decrease of at least 50% from baseline is considered an antidepressant response.
Time Frame baseline, 12 weeks of phase 1, 12 weeks of phase 2 and 12 weeks of phase 3 (bilateral stimulation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:

Active Stimulation of the left-sided electrode in the first phase (followed by right-sided stimulation in the second phase)

SCC DBS: Deep Brain Stimulator

Overall Number of Participants Analyzed 5
Mean (Full Range)
Unit of Measure: units on a scale
Baseline
22.35
(20.25 to 25.50)
12 weeks left-sided stimulation
18.8
(16 to 20)
12 weeks right-sided stimulation
21.4
(18 to 25)
12 weeks of bilateral stimulation
17.4
(6 to 22)
Time Frame 40 weeks following surgery to implant the DBS device
Adverse Event Reporting Description definitions do not differ
 
Arm/Group Title All Participants
Hide Arm/Group Description

Active Stimulation of the left-sided electrode in the first phase (followed by right-sided stimulation in the second phase)

SCC DBS: Deep Brain Stimulator

All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Nervous system disorders   
altered mental status * [1]  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
confusion related to oxycodone use post-surgery leading to emergency room visit (no hospitalization required)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
General disorders   
multiple  [1]  5/5 (100.00%)  38
Indicates events were collected by systematic assessment
[1]
Multiple mild adverse events were identified using the SAFTEE. Only 1 of 38 (pain at the IPG implantation site) was deemed to be related to the surgery or study device.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul E. Holtzheimer, MD
Organization: Dartmouth Hitchcock Medical Center
Phone: 603-650-4914
Responsible Party: Paul Holtzheimer, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01898429     History of Changes
Other Study ID Numbers: D12051
23293 ( Other Identifier: Dartmouth Committee for the Protection of Human Subjects )
First Submitted: July 9, 2013
First Posted: July 12, 2013
Results First Submitted: August 14, 2018
Results First Posted: September 12, 2018
Last Update Posted: September 12, 2018