ClinicalTrials.gov
ClinicalTrials.gov Menu

Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression

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.
ClinicalTrials.gov Identifier: NCT00837486
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Intervention: Device: Reclaim™ DBS System

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

Reporting Groups
  Description
Active Group-Active Stimulation Receive active stimulation during the first 16 weeks after device implant.
Control Group-Sham Stimulation Receive sham stimulation during the first 16 weeks after device implant.

Participant Flow for 2 periods

Period 1:   Blinded-treatment Phase
    Active Group-Active Stimulation   Control Group-Sham Stimulation
STARTED   16   14 
COMPLETED   15 [1]   14 
NOT COMPLETED   1   0 
Physician Decision                1                0 
[1] One subject did not receive the allocated intervention.

Period 2:   Long-term Follow-up Phase - Open Label
    Active Group-Active Stimulation   Control Group-Sham Stimulation
STARTED   29 [1]   0 
COMPLETED   24   0 
NOT COMPLETED   5   0 
Physician Decision                2                0 
Withdrawal by Subject                2                0 
Death                1                0 
[1] All subjects received open-label stimulation during this phase.



  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 enrolled participants are included.

Reporting Groups
  Description
Active Group-Active Stimulation Receive active stimulation during the first 16 weeks after device implant.
Control Group-Sham Stimulation Receive sham stimulation during the first 16 weeks after device implant.
Total Total of all reporting groups

Baseline Measures
   Active Group-Active Stimulation   Control Group-Sham Stimulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.6  (14.4)   48.9  (8.9)   47.7  (12.0) 
Gender 
[Units: Participants]
     
Female   8   5   13 
Male   8   9   17 
Region of Enrollment 
[Units: Participants]
     
United States   16   14   30 
Baseline depression score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 37.0  (5.1)   36.4  (3.3)   36.7  (4.3) 
[1] Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression)


  Outcome Measures

1.  Primary:   Responders   [ Time Frame: Baseline to 16 weeks ]

2.  Secondary:   Depression Change   [ Time Frame: Baseline to 16 weeks ]

3.  Secondary:   Quality of Life Change   [ Time Frame: Baseline to 16 weeks ]

4.  Other Pre-specified:   Long-term Open-label Responders   [ Time Frame: at the 24-month visit ]

5.  Other Pre-specified:   Therapy-related Adverse Events   [ Time Frame: from enrollment to study closure (average follow-up of 36 months) ]


  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
With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparisons of response rates and improvements were not adequately powered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Eric Williamson, Clinical Evidence Specialist
Organization: Medtronic Neuromodulation
phone: 763-526-7982
e-mail: medtronicneurotrials@medtronic.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00837486     History of Changes
Other Study ID Numbers: 1626
G080033
First Submitted: February 3, 2009
First Posted: February 5, 2009
Results First Submitted: March 13, 2015
Results First Posted: May 28, 2015
Last Update Posted: May 28, 2015