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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow for 3 periods

Period 1:   Phase 1
    Left-sided SCC DBS   Right-sided SCC DBS   Bilateral SCC DBS
STARTED   5   0   0 
COMPLETED   5   0   0 
NOT COMPLETED   0   0   0 

Period 2:   Phase 2
    Left-sided SCC DBS   Right-sided SCC DBS   Bilateral SCC DBS
STARTED   0   5   0 
COMPLETED   0   5   0 
NOT COMPLETED   0   0   0 

Period 3:   Phase 3
    Left-sided SCC DBS   Right-sided SCC DBS   Bilateral SCC DBS
STARTED   0   0   5 
COMPLETED   0   0   5 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

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.
All patients entered the left-sided phase first, then crossed over to the right-sided phase.

Reporting Groups
  Description
All 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


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (5.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  40.0% 
Male      3  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      5 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Units on a scale]
Mean (Standard Deviation)
 22.4  (2.0) 


  Outcome Measures

1.  Primary:   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)   [ Time Frame: baseline, 12 weeks of phase 1, 12 weeks of phase 2 and 12 weeks of phase 3 (bilateral stimulation) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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
e-mail: Paul.E.Holtzheimer@hitchcock.org



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