Trial Outcomes & Findings for Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD) (NCT NCT01898429)
NCT ID: NCT01898429
Last Updated: 2019-07-25
Results Overview
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.
COMPLETED
NA
5 participants
baseline, 12 weeks of phase 1, 12 weeks of phase 2 and 12 weeks of phase 3 (bilateral stimulation)
2019-07-25
Participant Flow
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.
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.
Participant milestones
| Measure |
Left-sided SCC DBS
Active Stimulation of the left-sided electrode
SCC DBS: Deep Brain Stimulator
|
Right-sided SCC DBS
Active stimulation of the right-sided electrode
SCC DBS: Deep Brain Stimulator
|
Bilateral SCC DBS
12 weeks of bilateral SCC DBS
|
|---|---|---|---|
|
Phase 1
STARTED
|
5
|
0
|
0
|
|
Phase 1
COMPLETED
|
5
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
5
|
0
|
|
Phase 2
COMPLETED
|
0
|
5
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 3
STARTED
|
0
|
0
|
5
|
|
Phase 3
COMPLETED
|
0
|
0
|
5
|
|
Phase 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)
Baseline characteristics by cohort
| Measure |
All Participants
n=5 Participants
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
|
|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Hamilton Depression Rating Scale (17 items)
|
22.4 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeks of phase 1, 12 weeks of phase 2 and 12 weeks of phase 3 (bilateral stimulation)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.
Outcome measures
| Measure |
All Participants
n=5 Participants
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
|
|---|---|
|
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)
12 weeks of bilateral stimulation
|
17.4 units on a scale
Interval 6.0 to 22.0
|
|
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)
Baseline
|
22.35 units on a scale
Interval 20.25 to 25.5
|
|
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)
12 weeks left-sided stimulation
|
18.8 units on a scale
Interval 16.0 to 20.0
|
|
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)
12 weeks right-sided stimulation
|
21.4 units on a scale
Interval 18.0 to 25.0
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=5 participants at risk
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
|
|---|---|
|
Nervous system disorders
altered mental status
|
20.0%
1/5 • Number of events 1 • 40 weeks following surgery to implant the DBS device
adverse events data were collected using the SAFTEE developed by the NIH
|
Other adverse events
| Measure |
All Participants
n=5 participants at risk
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
|
|---|---|
|
General disorders
multiple
|
100.0%
5/5 • Number of events 38 • 40 weeks following surgery to implant the DBS device
adverse events data were collected using the SAFTEE developed by the NIH
|
Additional Information
Paul E. Holtzheimer, MD
Dartmouth Hitchcock Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place