| Primary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | Nov 2010 | Least Squares Mean | Standard Error | units on a scale | | From Baseline to Study Week 22 | repeated measures IDS-C observations | Participants | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| | Units | Counts |
|---|
| Participants | | | repeated measures IDS-C observations | |
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-9.96± 0.99
- OG001-10.29± 1.00
- OG002-10.30± 0.97
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | Mixed Models Analysis | | 0.803 | | Mean Difference (Net) | 0.34 | | | 2-Sided | 95 | -2.34 | 3.02 | | | | No | Superiority or Other | |
|
| Secondary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Percent Sustained Responders at Study Week 50 (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From Baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 22 of the Acute Phase (ITT Population) | 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. | | Posted | | Number | | percentage of participants | | At Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | |
|
| Secondary | Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | At Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | |
|
| Secondary | Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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. | | Posted | | Number | | percentage of participants | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Post-Hoc | Regression Analysis of Change in IDS-C Score vs. Total Charge Delivered Per Day | 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. | | Posted | | Least Squares Mean | Standard Error | Units on a scale per log(mC/Day) | | 50 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Log Dose-Response Regression Coefficient | |
| |
| Post-Hoc | Regression Analysis of Change in MADRS Score vs. Total Charge Delivered Per Day | 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. | | Posted | | Least Squares Mean | Standard Error | Units on a scale per log(mC/Day) | | 50 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Log Dose-Response Regression Coefficient | |
| |
| Secondary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | mean percent change | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | units on a scale | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | mean percent change | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | units on a scale | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | mean percent change | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | units on a scale | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| 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). | 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 | | Posted | | Mean | Standard Deviation | mean percent change | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | units on a scale | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | mean percent change | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | units on a scale | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | mean percent change | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | units on a scale | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
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| Secondary | Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | mean percent change | | From baseline to Study Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
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| Secondary | Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | units on a scale | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |
| Secondary | Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population). | 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 | | Posted | | Mean | Standard Deviation | mean percent change | | From baseline to Study Week 50 | | | | ID | Title | Description |
|---|
| OG000 | Low Dose | Received output current 0.25 mA | | OG001 | Medium Dose | Received output current 0.5-1.0 mA | | OG002 | High Dose | Received output current 1.0-1.5 mA |
| |