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

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: NCT00305565
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : February 25, 2013
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Intervention Device: VNS Therapy
Enrollment 331
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description Received output current 0.25 milliamps (mA) Received output current 0.5-1.0 mA Received output current 1.0-1.5 mA
Period Title: Overall Study (Safety Population)
Started 111 107 113
Completed 97 95 106
Not Completed 14 12 7
Period Title: Overall Study (ITT Population)
Started 102 101 107
Completed 89 90 102
Not Completed 13 11 5
Arm/Group Title Low Dose Medium Dose High Dose Total
Hide Arm/Group Description Received output current 0.25 mA Received output current 0.5-1.0 mA Received output current 1.0-1.5 mA Total of all reporting groups
Overall Number of Baseline Participants 102 101 107 310
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 101 participants 107 participants 310 participants
49.1  (10.5) 47.2  (11.0) 47.4  (10.8) 47.9  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 107 participants 310 participants
Female
68
  66.7%
69
  68.3%
73
  68.2%
210
  67.7%
Male
34
  33.3%
32
  31.7%
34
  31.8%
100
  32.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 107 participants 310 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 102 participants 101 participants 107 participants 310 participants
102 101 107 310
Unipolar or Bipolar Depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 107 participants 310 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 107 participants 310 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]
Measure Description: This study specific characteristic data was not available for 1 participant in the Medium Dose Group.
Duration of Illness  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 101 participants 107 participants 310 participants
29.8  (12.1) 26.3  (10.9) 27.0  (12.1) 27.7  (11.8)
Length of Current Major Depressive Episode  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 102 participants 101 participants 107 participants 310 participants
106.7  (122.8) 106.1  (107.3) 111.3  (146.3) 108.1  (126.5)
1.Primary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.
Time Frame From Baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 102 101 107
Overall Number of Units Analyzed
Type of Units Analyzed: Repeated measures IDS-C observations
396 390 417
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.96  (0.99) -10.29  (1.00) -10.30  (0.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose, High Dose
Comments The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.803
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-2.34 to 3.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Dose, Medium Dose
Comments The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.813
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
-2.39 to 3.05
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline.

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Measure Type: Number
Unit of Measure: percentage of participants
16.5 17.5 21.0
3.Secondary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C.

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Measure Type: Number
Unit of Measure: percentage of participants
6.2 9.3 11.4
4.Secondary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Measure Type: Number
Unit of Measure: percentage of participants
27.0 38.9 27.5
5.Secondary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the IDS-C to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 16 17 22
Measure Type: Number
Unit of Measure: percentage of participants
43.8 88.2 81.8
6.Secondary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Measure Type: Number
Unit of Measure: percentage of participants
14.6 15.6 17.6
7.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.

The QIDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline.

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Measure Type: Number
Unit of Measure: percentage of participants
20.6 21.6 23.8
8.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.

The QIDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 5 on the QIDS-C.

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Measure Type: Number
Unit of Measure: percentage of participants
6.2 9.3 9.5
9.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.

The QIDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Measure Type: Number
Unit of Measure: percentage of participants
36.0 44.4 34.3
10.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.

The QIDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 5 on the QIDS-C.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Measure Type: Number
Unit of Measure: percentage of participants
15.7 16.7 16.7
11.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

The MADRS percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline.

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Measure Type: Number
Unit of Measure: percentage of participants
16.5 25.8 28.6
12.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

The MADRS percent of remitters at week 22. Remission was defined as a score of less than or equal to 9 on the MADRS.

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Measure Type: Number
Unit of Measure: percentage of participants
5.2 11.3 11.4
13.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

The MADRS percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Measure Type: Number
Unit of Measure: percentage of participants
36.0 47.8 37.3
14.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Percent Sustained Responders at Study Week 50 (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the MADRS to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy.

Time Frame From Baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 16 25 30
Measure Type: Number
Unit of Measure: percentage of participants
68.8 92.0 76.7
15.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

The MADRS percent of remitters at week 50. Remission was defined as a score of less than or equal to 9 on the MADRS.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Measure Type: Number
Unit of Measure: percentage of participants
22.5 21.1 22.5
16.Secondary Outcome
Title Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 22 of the Acute Phase (ITT Population)
Hide Description

Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)

In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit.

Time Frame At Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 96 105
Measure Type: Number
Unit of Measure: percentage of participants
20.6 28.1 31.4
17.Secondary Outcome
Title Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 50 of the Long-term Phase (ITT Population).
Hide Description

Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)

In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit.

Time Frame At Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Measure Type: Number
Unit of Measure: percentage of participants
41.6 53.3 48.0
18.Secondary Outcome
Title Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-SR percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline.

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 95 96 105
Measure Type: Number
Unit of Measure: percentage of participants
9.5 15.6 19.0
19.Secondary Outcome
Title Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-SR percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C.

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 95 96 105
Measure Type: Number
Unit of Measure: percentage of participants
5.3 9.4 11.4
20.Secondary Outcome
Title Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-SR percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 88 88 101
Measure Type: Number
Unit of Measure: percentage of participants
28.4 36.4 26.7
21.Secondary Outcome
Title Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-SR percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C.

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 88 88 101
Measure Type: Number
Unit of Measure: percentage of participants
17.0 17.0 14.9
22.Secondary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-C mean percent change at week 22

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Mean (Standard Deviation)
Unit of Measure: mean percent change
-22.3  (25.3) -24.9  (28.9) -25.4  (31.4)
23.Secondary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-C mean change at week 50

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
-16.9  (13.9) -17.0  (14.6) -15.3  (12.9)
24.Secondary Outcome
Title Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-C mean percent change at week 50

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Mean (Standard Deviation)
Unit of Measure: mean percent change
-36.6  (28.8) -36.5  (32.5) -34.6  (30.7)
25.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.

The QIDS-C mean change at week 22

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.4  (5.0) -5.0  (5.4) -4.7  (5.3)
26.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.

The QIDS-C mean percent change at week 22

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Mean (Standard Deviation)
Unit of Measure: mean percent change
-23.7  (27.4) -26.5  (29.8) -26.3  (31.6)
27.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.

The QIDS-C mean change at week 50

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.1  (5.7) -7.2  (6.2) -6.7  (5.1)
28.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.

The QIDS-C mean percent change at week 50

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Mean (Standard Deviation)
Unit of Measure: mean percent change
-37.9  (30.2) 38.5  (32.8) 38.2  (30.6)
29.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

The MADRS mean change at week 22

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.4  (8.8) -9.1  (10.7) -9.6  (11.0)
30.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

The MADRS mean percent change at week 22

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 97 97 105
Mean (Standard Deviation)
Unit of Measure: mean percent change
-25.0  (26.1) -26.7  (31.3) 28.2  (33.5)
31.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

The MADRS mean change at week 50

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.5  (11.6) -14.3  (11.6) -13.7  (10.8)
32.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

The MADRS mean percent change at week 50

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 89 90 102
Mean (Standard Deviation)
Unit of Measure: mean percent change
-39.3  (33.8) -42.0  (34.2) -40.8  (33.4)
33.Secondary Outcome
Title Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-SR mean change at week 22

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 95 96 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.0  (11.4) -11.1  (13.9) -10.2  (13.7)
34.Secondary Outcome
Title Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-SR mean percent change at week 22

Time Frame From baseline to Study Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 95 96 105
Mean (Standard Deviation)
Unit of Measure: mean percent change
-19.6  (24.7) -22.6  (29.4) -22.7  (31.1)
35.Secondary Outcome
Title Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-SR mean change at week 50

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 88 88 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.9  (15.0) -16.7  (15.0) -14.5  (13.5)
36.Secondary Outcome
Title Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
Hide Description

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

The IDS-SR mean percent change at week 50

Time Frame From baseline to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description:
Received output current 0.25 mA
Received output current 0.5-1.0 mA
Received output current 1.0-1.5 mA
Overall Number of Participants Analyzed 88 88 101
Mean (Standard Deviation)
Unit of Measure: mean percent change
-33.5  (29.6) -35.5  (32.2) -32.4  (31.3)
37.Post-Hoc Outcome
Title Regression Analysis of Change in IDS-C Score vs. Total Charge Delivered Per Day
Hide Description

Mixed models multivariate regression model was fitted for the outcome change from baseline IDS-C score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior electroconvulsive therapy (ECT) history, total number of adequate drug trials and prior medication regimen).

The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.

Time Frame 50 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
50 Week Completers
Arm/Group Title Log Dose-Response Regression Coefficient
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 314
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale per log(mC/Day)
-4.91  (1.34)
38.Post-Hoc Outcome
Title Regression Analysis of Change in MADRS Score vs. Total Charge Delivered Per Day
Hide Description

Mixed models multivariate regression model was fitted for the outcome change from baseline MADRS score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior ECT history, total number of adequate drug trials and prior medication regimen).

The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.

Time Frame 50 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
50 Week Completers
Arm/Group Title Log Dose-Response Regression Coefficient
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 314
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale per log(mC/Day)
-2.17  (0.93)
Time Frame 54 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Medium Dose High Dose
Hide Arm/Group Description Received output current 0.25 mA Received output current 0.5-1.0 mA Received output current 1.0-1.5 mA
All-Cause Mortality
Low Dose Medium Dose High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Low Dose Medium Dose High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/111 (27.93%)   19/107 (17.76%)   16/113 (14.16%) 
Cardiac disorders       
Cardiovascular System  1  1/111 (0.90%)  1/107 (0.93%)  1/113 (0.88%) 
Endocrine disorders       
Endocrine System  1  0/111 (0.00%)  1/107 (0.93%)  0/113 (0.00%) 
Gastrointestinal disorders       
Digestive System  1  3/111 (2.70%)  1/107 (0.93%)  1/113 (0.88%) 
General disorders       
Body as a Whole  1  19/111 (17.12%)  9/107 (8.41%)  13/113 (11.50%) 
Nervous system disorders       
Nervous System  1  9/111 (8.11%)  10/107 (9.35%)  4/113 (3.54%) 
Renal and urinary disorders       
Urogenital System  1  2/111 (1.80%)  1/107 (0.93%)  0/113 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory System  1  2/111 (1.80%)  1/107 (0.93%)  1/113 (0.88%) 
Skin and subcutaneous tissue disorders       
Skin and Appendages System  1  0/111 (0.00%)  1/107 (0.93%)  0/113 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Low Dose Medium Dose High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   103/111 (92.79%)   104/107 (97.20%)   111/113 (98.23%) 
Blood and lymphatic system disorders       
Hemic System  1  4/111 (3.60%)  2/107 (1.87%)  2/113 (1.77%) 
Cardiac disorders       
Cardiovascular System  1  12/111 (10.81%)  13/107 (12.15%)  15/113 (13.27%) 
Ear and labyrinth disorders       
Special Senses System  1  11/111 (9.91%)  6/107 (5.61%)  15/113 (13.27%) 
Endocrine disorders       
Endocrine System  1  4/111 (3.60%)  0/107 (0.00%)  1/113 (0.88%) 
Gastrointestinal disorders       
Digestive System  1  37/111 (33.33%)  45/107 (42.06%)  47/113 (41.59%) 
General disorders       
Body as a Whole  1  80/111 (72.07%)  78/107 (72.90%)  92/113 (81.42%) 
Metabolism and nutrition disorders       
Metabolic System  1  7/111 (6.31%)  9/107 (8.41%)  14/113 (12.39%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal System  1  6/111 (5.41%)  12/107 (11.21%)  11/113 (9.73%) 
Nervous system disorders       
Nervous System  1  73/111 (65.77%)  62/107 (57.94%)  85/113 (75.22%) 
Renal and urinary disorders       
Urogenital System  1  8/111 (7.21%)  13/107 (12.15%)  8/113 (7.08%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory System  1  87/111 (78.38%)  97/107 (90.65%)  99/113 (87.61%) 
Skin and subcutaneous tissue disorders       
Skin and Appendages System  1  9/111 (8.11%)  7/107 (6.54%)  6/113 (5.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Bunker Sr. Director, Global Medical Affairs
Organization: Cyberonics Inc.
Phone: 281-228-7223
EMail: Mark.Bunker@cyberonics.com
Other Publications:
Geddes LA, Baker LE: Principles of Applied Biomedical Instrumentation, third edition. New York; John Wiley & Sons, 1989; 458-461.
Layout table for additonal information
Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT00305565    
Other Study ID Numbers: D-21-US
First Submitted: March 20, 2006
First Posted: March 22, 2006
Results First Submitted: January 6, 2011
Results First Posted: February 25, 2013
Last Update Posted: January 7, 2014