Trial Outcomes & Findings for Deep Brain Stimulation for Treatment Resistant Depression (NCT NCT00367003)
NCT ID: NCT00367003
Last Updated: 2025-05-06
Results Overview
The Hamilton Depression Rating Scale (HDRS-17) contains 17 items that are scored from 0 to 2, 3, or 4, where 0 is lack of difficulty and the highest number for an item is the most extreme difficulty. Total scores range from 0 to 53 and higher scores indicate greater depression. For this study, a response to treatment will be defined as a decrease in the HDRS-17 score of 50% or greater from the average pre-surgical baseline.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Baseline, Week 24 post-intervention
Results posted on
2025-05-06
Participant Flow
37 participants were consented but only 28 participants underwent Subcallosal Cingulate Deep Brain Stimulation (DBS) between January 2007 and June 2013.
Participant milestones
| Measure |
Deep Brain Stimulation
Participants with treatment resistant depression will have a device implanted for deep brain stimulation.
Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.
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|---|---|
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Overall Study
STARTED
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37
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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9
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deep Brain Stimulation for Treatment Resistant Depression
Baseline characteristics by cohort
| Measure |
Deep Brain Stimulation
n=28 Participants
Participants with treatment resistant depression will have a device implanted for deep brain stimulation.
Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.
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|---|---|
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Age, Continuous
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44.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
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Sex: Female, Male
Female
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19 Participants
n=5 Participants
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Sex: Female, Male
Male
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9 Participants
n=5 Participants
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Race/Ethnicity, Customized
Caucasian
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27 Participants
n=5 Participants
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Race/Ethnicity, Customized
Not reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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28 participants
n=5 Participants
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Hamilton Depression Rating Scale Score
|
23.6 score on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
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Number of medications at time of implantation surgery
|
3.4 number of medications
STANDARD_DEVIATION 1.5 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 24 post-interventionThe Hamilton Depression Rating Scale (HDRS-17) contains 17 items that are scored from 0 to 2, 3, or 4, where 0 is lack of difficulty and the highest number for an item is the most extreme difficulty. Total scores range from 0 to 53 and higher scores indicate greater depression. For this study, a response to treatment will be defined as a decrease in the HDRS-17 score of 50% or greater from the average pre-surgical baseline.
Outcome measures
| Measure |
Deep Brain Stimulation
n=28 Participants
Participants with treatment resistant depression will have a device implanted for deep brain stimulation.
Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.
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|---|---|
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Change in Hamilton Depression Rating Scale-17 Score
Baseline
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23.6 score on a scale
Standard Deviation 2.9
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Change in Hamilton Depression Rating Scale-17 Score
Week 24 post-intervention
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11.66 score on a scale
Standard Deviation 2.6
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Adverse Events
Deep Brain Stimulation
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deep Brain Stimulation
n=28 participants at risk
Participants with treatment resistant depression will have a device implanted for deep brain stimulation.
Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.
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|---|---|
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General disorders
Infection
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7.1%
2/28 • Number of events 2 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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General disorders
Syncope
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Nervous system disorders
Seizure
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Injury, poisoning and procedural complications
Cap Erosion with dehissence of suture line
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Psychiatric disorders
Suicide Attempt
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Psychiatric disorders
Axiety requiring hospitalization
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Other adverse events
| Measure |
Deep Brain Stimulation
n=28 participants at risk
Participants with treatment resistant depression will have a device implanted for deep brain stimulation.
Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.
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|---|---|
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Nervous system disorders
Paresthesia
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7.1%
2/28 • Number of events 2 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Respiratory, thoracic and mediastinal disorders
Bronchitis
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Gastrointestinal disorders
Nausea
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10.7%
3/28 • Number of events 4 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Psychiatric disorders
Worsening Depression
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10.7%
3/28 • Number of events 3 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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General disorders
Weakness
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Injury, poisoning and procedural complications
DBS system revision as a result of dislodgement
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Infections and infestations
Sinus Infection
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Infections and infestations
Infection
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7.1%
2/28 • Number of events 2 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Nervous system disorders
Headache
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Injury, poisoning and procedural complications
Car accident
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Psychiatric disorders
Panic attack
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Psychiatric disorders
Anxiety
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3.6%
1/28 • Number of events 1 • Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place