Trial Outcomes & Findings for Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses (NCT NCT00305565)
NCT ID: NCT00305565
Last Updated: 2014-01-07
Results Overview
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.
COMPLETED
PHASE4
331 participants
From Baseline to Study Week 22
2014-01-07
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study (Safety Population)
STARTED
|
111
|
107
|
113
|
|
Overall Study (Safety Population)
COMPLETED
|
97
|
95
|
106
|
|
Overall Study (Safety Population)
NOT COMPLETED
|
14
|
12
|
7
|
|
Overall Study (ITT Population)
STARTED
|
102
|
101
|
107
|
|
Overall Study (ITT Population)
COMPLETED
|
89
|
90
|
102
|
|
Overall Study (ITT Population)
NOT COMPLETED
|
13
|
11
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses
Baseline characteristics by cohort
| Measure |
Low Dose
n=102 Participants
Received output current 0.25 mA
|
Medium Dose
n=101 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=107 Participants
Received output current 1.0-1.5 mA
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
47.2 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
47.4 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
47.9 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
210 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
100 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
97 participants
n=99 Participants
|
96 participants
n=107 Participants
|
104 participants
n=206 Participants
|
297 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
African-American
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=99 Participants
|
101 participants
n=107 Participants
|
107 participants
n=206 Participants
|
310 participants
n=7 Participants
|
|
Unipolar or Bipolar Depression
Unipolar Depression (Single Episode)
|
6 participants
n=99 Participants
|
10 participants
n=107 Participants
|
15 participants
n=206 Participants
|
31 participants
n=7 Participants
|
|
Unipolar or Bipolar Depression
Unipolar Depression (Recurrent)
|
76 participants
n=99 Participants
|
71 participants
n=107 Participants
|
66 participants
n=206 Participants
|
213 participants
n=7 Participants
|
|
Unipolar or Bipolar Depression
Bipolar Depression
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
26 participants
n=206 Participants
|
66 participants
n=7 Participants
|
|
Lifetime Episodes of Depression
0-2 Episodes
|
16 participants
n=99 Participants
|
17 participants
n=107 Participants
|
28 participants
n=206 Participants
|
61 participants
n=7 Participants
|
|
Lifetime Episodes of Depression
3-5 Episodes
|
23 participants
n=99 Participants
|
21 participants
n=107 Participants
|
22 participants
n=206 Participants
|
66 participants
n=7 Participants
|
|
Lifetime Episodes of Depression
6-10 Episodes
|
13 participants
n=99 Participants
|
16 participants
n=107 Participants
|
18 participants
n=206 Participants
|
47 participants
n=7 Participants
|
|
Lifetime Episodes of Depression
>10 Episodes
|
50 participants
n=99 Participants
|
46 participants
n=107 Participants
|
39 participants
n=206 Participants
|
135 participants
n=7 Participants
|
|
Duration of Illness
|
29.8 Years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
26.3 Years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
27.0 Years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
27.7 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
|
Length of Current Major Depressive Episode
|
106.7 Months
STANDARD_DEVIATION 122.8 • n=99 Participants
|
106.1 Months
STANDARD_DEVIATION 107.3 • n=107 Participants
|
111.3 Months
STANDARD_DEVIATION 146.3 • n=206 Participants
|
108.1 Months
STANDARD_DEVIATION 126.5 • n=7 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=396 repeated measures IDS-C observations
Received output current 0.25 mA
|
Medium Dose
n=390 repeated measures IDS-C observations
Received output current 0.5-1.0 mA
|
High Dose
n=417 repeated measures IDS-C observations
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).
|
-9.96 units on a scale
Standard Error 0.99
|
-10.29 units on a scale
Standard Error 1.00
|
-10.30 units on a scale
Standard Error 0.97
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).
|
16.5 percentage of participants
|
17.5 percentage of participants
|
21.0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).
|
6.2 percentage of participants
|
9.3 percentage of participants
|
11.4 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
27.0 percentage of participants
|
38.9 percentage of participants
|
27.5 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=16 Participants
Received output current 0.25 mA
|
Medium Dose
n=17 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=22 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population).
|
43.8 percentage of participants
|
88.2 percentage of participants
|
81.8 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
14.6 percentage of participants
|
15.6 percentage of participants
|
17.6 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).
|
20.6 percentage of participants
|
21.6 percentage of participants
|
23.8 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).
|
6.2 percentage of participants
|
9.3 percentage of participants
|
9.5 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
36.0 percentage of participants
|
44.4 percentage of participants
|
34.3 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
15.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).
|
16.5 percentage of participants
|
25.8 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).
|
5.2 percentage of participants
|
11.3 percentage of participants
|
11.4 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
36.0 percentage of participants
|
47.8 percentage of participants
|
37.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=16 Participants
Received output current 0.25 mA
|
Medium Dose
n=25 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=30 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Percent Sustained Responders at Study Week 50 (ITT Population).
|
68.8 percentage of participants
|
92.0 percentage of participants
|
76.7 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
22.5 percentage of participants
|
21.1 percentage of participants
|
22.5 percentage of participants
|
SECONDARY outcome
Timeframe: At Study Week 22Originally, 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.
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=96 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 22 of the Acute Phase (ITT Population)
|
20.6 percentage of participants
|
28.1 percentage of participants
|
31.4 percentage of participants
|
SECONDARY outcome
Timeframe: At Study Week 50Originally, 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.
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 50 of the Long-term Phase (ITT Population).
|
41.6 percentage of participants
|
53.3 percentage of participants
|
48.0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=95 Participants
Received output current 0.25 mA
|
Medium Dose
n=96 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).
|
9.5 percentage of participants
|
15.6 percentage of participants
|
19.0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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.
Outcome measures
| Measure |
Low Dose
n=95 Participants
Received output current 0.25 mA
|
Medium Dose
n=96 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).
|
5.3 percentage of participants
|
9.4 percentage of participants
|
11.4 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=88 Participants
Received output current 0.25 mA
|
Medium Dose
n=88 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=101 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
28.4 percentage of participants
|
36.4 percentage of participants
|
26.7 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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.
Outcome measures
| Measure |
Low Dose
n=88 Participants
Received output current 0.25 mA
|
Medium Dose
n=88 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=101 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
17.0 percentage of participants
|
17.0 percentage of participants
|
14.9 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).
|
-22.3 mean percent change
Standard Deviation 25.3
|
-24.9 mean percent change
Standard Deviation 28.9
|
-25.4 mean percent change
Standard Deviation 31.4
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
-16.9 units on a scale
Standard Deviation 13.9
|
-17.0 units on a scale
Standard Deviation 14.6
|
-15.3 units on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
-36.6 mean percent change
Standard Deviation 28.8
|
-36.5 mean percent change
Standard Deviation 32.5
|
-34.6 mean percent change
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).
|
-4.4 units on a scale
Standard Deviation 5.0
|
-5.0 units on a scale
Standard Deviation 5.4
|
-4.7 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).
|
-23.7 mean percent change
Standard Deviation 27.4
|
-26.5 mean percent change
Standard Deviation 29.8
|
-26.3 mean percent change
Standard Deviation 31.6
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
-7.1 units on a scale
Standard Deviation 5.7
|
-7.2 units on a scale
Standard Deviation 6.2
|
-6.7 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
-37.9 mean percent change
Standard Deviation 30.2
|
38.5 mean percent change
Standard Deviation 32.8
|
38.2 mean percent change
Standard Deviation 30.6
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).
|
-8.4 units on a scale
Standard Deviation 8.8
|
-9.1 units on a scale
Standard Deviation 10.7
|
-9.6 units on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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
Outcome measures
| Measure |
Low Dose
n=97 Participants
Received output current 0.25 mA
|
Medium Dose
n=97 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).
|
-25.0 mean percent change
Standard Deviation 26.1
|
-26.7 mean percent change
Standard Deviation 31.3
|
28.2 mean percent change
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
-13.5 units on a scale
Standard Deviation 11.6
|
-14.3 units on a scale
Standard Deviation 11.6
|
-13.7 units on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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
Outcome measures
| Measure |
Low Dose
n=89 Participants
Received output current 0.25 mA
|
Medium Dose
n=90 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=102 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
-39.3 mean percent change
Standard Deviation 33.8
|
-42.0 mean percent change
Standard Deviation 34.2
|
-40.8 mean percent change
Standard Deviation 33.4
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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
Outcome measures
| Measure |
Low Dose
n=95 Participants
Received output current 0.25 mA
|
Medium Dose
n=96 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).
|
-9.0 units on a scale
Standard Deviation 11.4
|
-11.1 units on a scale
Standard Deviation 13.9
|
-10.2 units on a scale
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: From baseline to Study Week 22The 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
Outcome measures
| Measure |
Low Dose
n=95 Participants
Received output current 0.25 mA
|
Medium Dose
n=96 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=105 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).
|
-19.6 mean percent change
Standard Deviation 24.7
|
-22.6 mean percent change
Standard Deviation 29.4
|
-22.7 mean percent change
Standard Deviation 31.1
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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
Outcome measures
| Measure |
Low Dose
n=88 Participants
Received output current 0.25 mA
|
Medium Dose
n=88 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=101 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
-15.9 units on a scale
Standard Deviation 15.0
|
-16.7 units on a scale
Standard Deviation 15.0
|
-14.5 units on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: From baseline to Study Week 50The 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
Outcome measures
| Measure |
Low Dose
n=88 Participants
Received output current 0.25 mA
|
Medium Dose
n=88 Participants
Received output current 0.5-1.0 mA
|
High Dose
n=101 Participants
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).
|
-33.5 mean percent change
Standard Deviation 29.6
|
-35.5 mean percent change
Standard Deviation 32.2
|
-32.4 mean percent change
Standard Deviation 31.3
|
POST_HOC outcome
Timeframe: 50 WeeksPopulation: 50 Week Completers
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.
Outcome measures
| Measure |
Low Dose
n=314 Participants
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
|
|---|---|---|---|
|
Regression Analysis of Change in IDS-C Score vs. Total Charge Delivered Per Day
|
-4.91 Units on a scale per log(mC/Day)
Standard Error 1.34
|
—
|
—
|
POST_HOC outcome
Timeframe: 50 WeeksPopulation: 50 Week Completers
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.
Outcome measures
| Measure |
Low Dose
n=314 Participants
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
|
|---|---|---|---|
|
Regression Analysis of Change in MADRS Score vs. Total Charge Delivered Per Day
|
-2.17 Units on a scale per log(mC/Day)
Standard Error 0.93
|
—
|
—
|
Adverse Events
Low Dose
Medium Dose
High Dose
Serious adverse events
| Measure |
Low Dose
n=111 participants at risk
Received output current 0.25 mA
|
Medium Dose
n=107 participants at risk
Received output current 0.5-1.0 mA
|
High Dose
n=113 participants at risk
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
General disorders
Body as a Whole
|
17.1%
19/111 • 54 Weeks
|
8.4%
9/107 • 54 Weeks
|
11.5%
13/113 • 54 Weeks
|
|
Cardiac disorders
Cardiovascular System
|
0.90%
1/111 • 54 Weeks
|
0.93%
1/107 • 54 Weeks
|
0.88%
1/113 • 54 Weeks
|
|
Gastrointestinal disorders
Digestive System
|
2.7%
3/111 • 54 Weeks
|
0.93%
1/107 • 54 Weeks
|
0.88%
1/113 • 54 Weeks
|
|
Endocrine disorders
Endocrine System
|
0.00%
0/111 • 54 Weeks
|
0.93%
1/107 • 54 Weeks
|
0.00%
0/113 • 54 Weeks
|
|
Nervous system disorders
Nervous System
|
8.1%
9/111 • 54 Weeks
|
9.3%
10/107 • 54 Weeks
|
3.5%
4/113 • 54 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory System
|
1.8%
2/111 • 54 Weeks
|
0.93%
1/107 • 54 Weeks
|
0.88%
1/113 • 54 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin and Appendages System
|
0.00%
0/111 • 54 Weeks
|
0.93%
1/107 • 54 Weeks
|
0.00%
0/113 • 54 Weeks
|
|
Renal and urinary disorders
Urogenital System
|
1.8%
2/111 • 54 Weeks
|
0.93%
1/107 • 54 Weeks
|
0.00%
0/113 • 54 Weeks
|
Other adverse events
| Measure |
Low Dose
n=111 participants at risk
Received output current 0.25 mA
|
Medium Dose
n=107 participants at risk
Received output current 0.5-1.0 mA
|
High Dose
n=113 participants at risk
Received output current 1.0-1.5 mA
|
|---|---|---|---|
|
General disorders
Body as a Whole
|
72.1%
80/111 • 54 Weeks
|
72.9%
78/107 • 54 Weeks
|
81.4%
92/113 • 54 Weeks
|
|
Cardiac disorders
Cardiovascular System
|
10.8%
12/111 • 54 Weeks
|
12.1%
13/107 • 54 Weeks
|
13.3%
15/113 • 54 Weeks
|
|
Gastrointestinal disorders
Digestive System
|
33.3%
37/111 • 54 Weeks
|
42.1%
45/107 • 54 Weeks
|
41.6%
47/113 • 54 Weeks
|
|
Endocrine disorders
Endocrine System
|
3.6%
4/111 • 54 Weeks
|
0.00%
0/107 • 54 Weeks
|
0.88%
1/113 • 54 Weeks
|
|
Blood and lymphatic system disorders
Hemic System
|
3.6%
4/111 • 54 Weeks
|
1.9%
2/107 • 54 Weeks
|
1.8%
2/113 • 54 Weeks
|
|
Metabolism and nutrition disorders
Metabolic System
|
6.3%
7/111 • 54 Weeks
|
8.4%
9/107 • 54 Weeks
|
12.4%
14/113 • 54 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal System
|
5.4%
6/111 • 54 Weeks
|
11.2%
12/107 • 54 Weeks
|
9.7%
11/113 • 54 Weeks
|
|
Nervous system disorders
Nervous System
|
65.8%
73/111 • 54 Weeks
|
57.9%
62/107 • 54 Weeks
|
75.2%
85/113 • 54 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory System
|
78.4%
87/111 • 54 Weeks
|
90.7%
97/107 • 54 Weeks
|
87.6%
99/113 • 54 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin and Appendages System
|
8.1%
9/111 • 54 Weeks
|
6.5%
7/107 • 54 Weeks
|
5.3%
6/113 • 54 Weeks
|
|
Ear and labyrinth disorders
Special Senses System
|
9.9%
11/111 • 54 Weeks
|
5.6%
6/107 • 54 Weeks
|
13.3%
15/113 • 54 Weeks
|
|
Renal and urinary disorders
Urogenital System
|
7.2%
8/111 • 54 Weeks
|
12.1%
13/107 • 54 Weeks
|
7.1%
8/113 • 54 Weeks
|
Additional Information
Mark Bunker Sr. Director, Global Medical Affairs
Cyberonics Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60