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Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT00305565
First received: March 20, 2006
Last updated: December 6, 2013
Last verified: December 2013
Results First Received: January 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Intervention: Device: VNS Therapy

  Participant Flow
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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
A total of 331 subjects at 29 sites were actually enrolled and implanted with the Vagus Nerve Stimulation (VNS) Therapy System, and were included in the safety dataset. Twenty-one subjects were excluded from the intent-to-treat (ITT) dataset, leaving 310 in the ITT population.

Reporting Groups
  Description
Low Dose Received output current 0.25 milliamps (mA)
Medium Dose Received output current 0.5-1.0 mA
High Dose Received output current 1.0-1.5 mA

Participant Flow for 2 periods

Period 1:   Overall Study (Safety Population)
    Low Dose   Medium Dose   High Dose
STARTED   111   107   113 
COMPLETED   97   95   106 
NOT COMPLETED   14   12   7 

Period 2:   Overall Study (ITT Population)
    Low Dose   Medium Dose   High Dose
STARTED   102   101   107 
COMPLETED   89   90   102 
NOT COMPLETED   13   11   5 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Low Dose Received output current 0.25 mA
Medium Dose Received output current 0.5-1.0 mA
High Dose Received output current 1.0-1.5 mA
Total Total of all reporting groups

Baseline Measures
   Low Dose   Medium Dose   High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 102   101   107   310 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.1  (10.5)   47.2  (11.0)   47.4  (10.8)   47.9  (10.8) 
Gender 
[Units: Participants]
       
Female   68   69   73   210 
Male   34   32   34   100 
Race/Ethnicity, Customized 
[Units: Participants]
       
Caucasian   97   96   104   297 
Asian   3   1   0   4 
African-American   2   3   3   8 
Hispanic   0   1   0   1 
Region of Enrollment 
[Units: Participants]
       
United States   102   101   107   310 
Unipolar or Bipolar Depression 
[Units: Participants]
       
Unipolar Depression (Single Episode)   6   10   15   31 
Unipolar Depression (Recurrent)   76   71   66   213 
Bipolar Depression   20   20   26   66 
Lifetime Episodes of Depression [1] 
[Units: Participants]
       
0-2 Episodes   16   17   28   61 
3-5 Episodes   23   21   22   66 
6-10 Episodes   13   16   18   47 
>10 Episodes   50   46   39   135 
[1] This study specific characteristic data was not available for 1 participant in the Medium Dose Group.
Duration of Illness 
[Units: Years]
Mean (Standard Deviation)
 29.8  (12.1)   26.3  (10.9)   27.0  (12.1)   27.7  (11.8) 
Length of Current Major Depressive Episode 
[Units: Months]
Mean (Standard Deviation)
 106.7  (122.8)   106.1  (107.3)   111.3  (146.3)   108.1  (126.5) 


  Outcome Measures
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1.  Primary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From Baseline to Study Week 22 ]

2.  Secondary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

3.  Secondary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

4.  Secondary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

5.  Secondary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

6.  Secondary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

7.  Secondary:   Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

8.  Secondary:   Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

9.  Secondary:   Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

10.  Secondary:   Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

11.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

12.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

13.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

14.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Percent Sustained Responders at Study Week 50 (ITT Population).   [ Time Frame: From Baseline to Study Week 50 ]

15.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

16.  Secondary:   Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 22 of the Acute Phase (ITT Population)   [ Time Frame: At Study Week 22 ]

17.  Secondary:   Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: At Study Week 50 ]

18.  Secondary:   Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

19.  Secondary:   Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

20.  Secondary:   Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

21.  Secondary:   Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

22.  Secondary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

23.  Secondary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

24.  Secondary:   Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

25.  Secondary:   Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

26.  Secondary:   Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

27.  Secondary:   Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

28.  Secondary:   Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

29.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

30.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

31.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

32.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

33.  Secondary:   Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

34.  Secondary:   Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).   [ Time Frame: From baseline to Study Week 22 ]

35.  Secondary:   Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

36.  Secondary:   Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).   [ Time Frame: From baseline to Study Week 50 ]

37.  Post-Hoc:   Regression Analysis of Change in IDS-C Score vs. Total Charge Delivered Per Day   [ Time Frame: 50 Weeks ]

38.  Post-Hoc:   Regression Analysis of Change in MADRS Score vs. Total Charge Delivered Per Day   [ Time Frame: 50 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Bunker Sr. Director, Global Medical Affairs
Organization: Cyberonics Inc.
phone: 281-228-7223
e-mail: Mark.Bunker@cyberonics.com


Publications of Results:
Other Publications:
Geddes LA, Baker LE: Principles of Applied Biomedical Instrumentation, third edition. New York; John Wiley & Sons, 1989; 458-461.


Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT00305565     History of Changes
Other Study ID Numbers: D-21-US
Study First Received: March 20, 2006
Results First Received: January 6, 2011
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board