Trial | Outcome |
NCT00596817 (9) [back to overview] | Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment |
NCT00596817 (9) [back to overview] | Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator |
NCT00596817 (9) [back to overview] | Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator |
NCT00596817 (9) [back to overview] | Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline) |
NCT00596817 (9) [back to overview] | Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment |
NCT00596817 (9) [back to overview] | Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment |
NCT00596817 (9) [back to overview] | Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period |
NCT00596817 (9) [back to overview] | Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10) |
NCT00596817 (9) [back to overview] | Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment |
NCT00635219 (10) [back to overview] | Change in Clinical Status Using CGI-I Score at Week 8 |
NCT00635219 (10) [back to overview] | Change From Baseline in ASEX Total Score After 8 Weeks of Treatment |
NCT00635219 (10) [back to overview] | Change From Baseline in CGI-S Score After 8 Weeks of Treatment |
NCT00635219 (10) [back to overview] | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment |
NCT00635219 (10) [back to overview] | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment |
NCT00635219 (10) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment |
NCT00635219 (10) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 |
NCT00635219 (10) [back to overview] | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
NCT00635219 (10) [back to overview] | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) |
NCT00635219 (10) [back to overview] | Change From Baseline in SDS Total Score After 8 Weeks of Treatment |
NCT00672620 (12) [back to overview] | Clinical Global Impression Scale-Global Improvement Scale |
NCT00672620 (12) [back to overview] | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire |
NCT00672620 (12) [back to overview] | Percentage of Responders in HAM-D 24 Total Score by Study Visit |
NCT00672620 (12) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score |
NCT00672620 (12) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
NCT00672620 (12) [back to overview] | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8 |
NCT00672620 (12) [back to overview] | Percentage of Participants in MADRS Remission at Week 8 |
NCT00672620 (12) [back to overview] | Percentage of Participants With a Sustained Response in HAM-D24 |
NCT00672620 (12) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) |
NCT00672620 (12) [back to overview] | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed |
NCT00672620 (12) [back to overview] | Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale |
NCT00672620 (12) [back to overview] | Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score |
NCT00672958 (13) [back to overview] | Percentage of Responders in HAM-D24 Total Score by Study Visit |
NCT00672958 (13) [back to overview] | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire |
NCT00672958 (13) [back to overview] | Clinical Global Impression Scale-Global Improvement Scale |
NCT00672958 (13) [back to overview] | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed |
NCT00672958 (13) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) |
NCT00672958 (13) [back to overview] | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score |
NCT00672958 (13) [back to overview] | Change From Baseline in Hamilton Anxiety Scale (HAM-A) |
NCT00672958 (13) [back to overview] | Change From Baseline in Clinical Global Impression Scale-Severity of Illness |
NCT00672958 (13) [back to overview] | Change From Baseline in 36-item Short-form Health Survey (SF-36) at Week 6 |
NCT00672958 (13) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6 |
NCT00672958 (13) [back to overview] | Percentage of Participants With a Sustained Response in HAM-D24 |
NCT00672958 (13) [back to overview] | Percentage of Participants in MADRS Remission at Week 6 |
NCT00672958 (13) [back to overview] | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6 |
NCT00694304 (10) [back to overview] | Change From Baseline in CGI-S Score After 52 Weeks of Treatment |
NCT00694304 (10) [back to overview] | Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment |
NCT00694304 (10) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment |
NCT00694304 (10) [back to overview] | Change From Baseline in MADRS Total Score After 52 Weeks of Treatment |
NCT00694304 (10) [back to overview] | Change From Baseline in SDS Total Score After 52 Weeks of Treatment |
NCT00694304 (10) [back to overview] | Percentage of Patients Who Withdrew Due to Intolerance to Treatment |
NCT00694304 (10) [back to overview] | Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment |
NCT00694304 (10) [back to overview] | Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) |
NCT00694304 (10) [back to overview] | Number of Patients With Adverse Events (AEs) |
NCT00694304 (10) [back to overview] | Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) |
NCT00707980 (12) [back to overview] | Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire |
NCT00707980 (12) [back to overview] | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings |
NCT00707980 (12) [back to overview] | Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings |
NCT00707980 (12) [back to overview] | Number of Participants With Potentially Clinically Significant Vital Sign Findings |
NCT00707980 (12) [back to overview] | Physical Examination Findings |
NCT00707980 (12) [back to overview] | Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score |
NCT00707980 (12) [back to overview] | Change From Baseline to the Final Visit in the Sheehan Disability Scale |
NCT00707980 (12) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT00707980 (12) [back to overview] | Change From Baseline in the Clinical Global Impression of Severity of Illness Scale |
NCT00707980 (12) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score |
NCT00707980 (12) [back to overview] | Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score |
NCT00707980 (12) [back to overview] | Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36) |
NCT00730691 (16) [back to overview] | Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed |
NCT00730691 (16) [back to overview] | Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire |
NCT00730691 (16) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 |
NCT00730691 (16) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed |
NCT00730691 (16) [back to overview] | Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed |
NCT00730691 (16) [back to overview] | Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed |
NCT00730691 (16) [back to overview] | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed |
NCT00730691 (16) [back to overview] | Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S) |
NCT00730691 (16) [back to overview] | Percentage of Responders in HAM-A Total Score at Week 8 |
NCT00730691 (16) [back to overview] | Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8 |
NCT00730691 (16) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 |
NCT00730691 (16) [back to overview] | Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8 |
NCT00730691 (16) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) at Week 8 |
NCT00730691 (16) [back to overview] | Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8 |
NCT00730691 (16) [back to overview] | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed |
NCT00730691 (16) [back to overview] | Percentage of Participants in HAM-A Remission at Each Week Assessed |
NCT00731120 (10) [back to overview] | Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed |
NCT00731120 (10) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) at Week 8 |
NCT00731120 (10) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score |
NCT00731120 (10) [back to overview] | Percentage of Participants in HAM-A Remission at Week 8 |
NCT00731120 (10) [back to overview] | Percentage of Responders in HAM-A Total Score at Week 8 |
NCT00731120 (10) [back to overview] | Change From Baseline in 36-item Short-form Health Survey (SF-36) |
NCT00731120 (10) [back to overview] | Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S) |
NCT00731120 (10) [back to overview] | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed |
NCT00731120 (10) [back to overview] | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales |
NCT00731120 (10) [back to overview] | Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8 |
NCT00734071 (25) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
NCT00734071 (25) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 |
NCT00734071 (25) [back to overview] | Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8 |
NCT00734071 (25) [back to overview] | Clinical Global Impression Scale-Global Improvement at Week 8 |
NCT00734071 (25) [back to overview] | Percentage of Responders in HAM-A Total Score at Week 8 |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 |
NCT00734071 (25) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed |
NCT00734071 (25) [back to overview] | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed |
NCT00734071 (25) [back to overview] | Percentage of Participants in HAM-A Remission at Each Week Assessed |
NCT00734071 (25) [back to overview] | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire |
NCT00734071 (25) [back to overview] | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 |
NCT00734071 (25) [back to overview] | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed |
NCT00734071 (25) [back to overview] | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 |
NCT00735709 (26) [back to overview] | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week |
NCT00735709 (26) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed |
NCT00735709 (26) [back to overview] | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20 |
NCT00735709 (26) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed |
NCT00735709 (26) [back to overview] | Percentage of Responders in HAM-D24 Total Score at Week 8 |
NCT00735709 (26) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed |
NCT00735709 (26) [back to overview] | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. |
NCT00735709 (26) [back to overview] | Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 |
NCT00735709 (26) [back to overview] | Percentage of Participants in MADRS Remission at Other Weeks Assessed |
NCT00735709 (26) [back to overview] | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed |
NCT00735709 (26) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed |
NCT00735709 (26) [back to overview] | Percentage of Participants With a Sustained Response in HAM-D24 Total Score |
NCT00735709 (26) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed |
NCT00735709 (26) [back to overview] | Percentage of Participants in MADRS Remission at Week 8 |
NCT00735709 (26) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed |
NCT00735709 (26) [back to overview] | Clinical Global Impression Scale-Global Improvement at Week 8 |
NCT00735709 (26) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8 |
NCT00744627 (25) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
NCT00744627 (25) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 |
NCT00744627 (25) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 |
NCT00744627 (25) [back to overview] | Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8 |
NCT00744627 (25) [back to overview] | Clinical Global Impression Scale-Global Improvement at Week 8 |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 |
NCT00744627 (25) [back to overview] | Percentage of Participants in HAM-A Remission at Each Week Assessed |
NCT00744627 (25) [back to overview] | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed |
NCT00744627 (25) [back to overview] | Percentage of Responders in HAM-A Total Score at Week 8 |
NCT00744627 (25) [back to overview] | Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed |
NCT00744627 (25) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed |
NCT00744627 (25) [back to overview] | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed |
NCT00744627 (25) [back to overview] | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire |
NCT00761306 (6) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment |
NCT00761306 (6) [back to overview] | Number of Patients With Adverse Events (AEs) |
NCT00761306 (6) [back to overview] | Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) |
NCT00761306 (6) [back to overview] | Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) |
NCT00761306 (6) [back to overview] | Percentage of Patients Who Withdrew Due to Intolerance to Treatment |
NCT00761306 (6) [back to overview] | Change From Baseline in MADRS Total Score After 52 Weeks of Treatment |
NCT00811252 (13) [back to overview] | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment |
NCT00811252 (13) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment |
NCT00811252 (13) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment |
NCT00811252 (13) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment |
NCT00811252 (13) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment |
NCT00811252 (13) [back to overview] | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment |
NCT00811252 (13) [back to overview] | Change From Baseline in CGI-S Score After 8 Weeks of Treatment |
NCT00811252 (13) [back to overview] | Risk of Suicidality Using C-SSRS Scores |
NCT00811252 (13) [back to overview] | Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) |
NCT00811252 (13) [back to overview] | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) |
NCT00811252 (13) [back to overview] | Change in Clinical Status Using CGI-I Score at Week 8 |
NCT00811252 (13) [back to overview] | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment |
NCT00811252 (13) [back to overview] | Change From Baseline in GDS Total Score After 8 Weeks of Treatment |
NCT00839423 (8) [back to overview] | Change From Baseline in MADRS Total Score After 1 Week of Treatment |
NCT00839423 (8) [back to overview] | Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment |
NCT00839423 (8) [back to overview] | Change From Baseline in CGI-S Score After 6 Weeks of Treatment |
NCT00839423 (8) [back to overview] | Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
NCT00839423 (8) [back to overview] | Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10) |
NCT00839423 (8) [back to overview] | Change in Clinical Status Using CGI-I Score at Week 6 |
NCT00839423 (8) [back to overview] | Change From Baseline in MADRS Total Score After 6 Weeks of Treatment |
NCT00839423 (8) [back to overview] | Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment |
NCT01140906 (8) [back to overview] | Change From Baseline in ASEX Total Score After 8 Weeks of Treatment |
NCT01140906 (8) [back to overview] | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20 |
NCT01140906 (8) [back to overview] | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment. |
NCT01140906 (8) [back to overview] | Change From Baseline in SDS Total Score After 8 Weeks of Treatment |
NCT01140906 (8) [back to overview] | Change in Clinical Status Using CGI-I Score at Week 8 |
NCT01140906 (8) [back to overview] | Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine |
NCT01140906 (8) [back to overview] | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) |
NCT01140906 (8) [back to overview] | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
NCT01152996 (10) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score |
NCT01152996 (10) [back to overview] | Number of Participants With Serious Treatment-Emergent Adverse Events |
NCT01152996 (10) [back to overview] | Treatment-Emergent Adverse Events Leading to Study Discontinuation |
NCT01152996 (10) [back to overview] | Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S) |
NCT01152996 (10) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
NCT01152996 (10) [back to overview] | Change From Baseline in SDS Family Life/Home Responsibilities Subscale |
NCT01152996 (10) [back to overview] | Change From Baseline in SDS Social Life Subscale |
NCT01152996 (10) [back to overview] | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score |
NCT01152996 (10) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5% |
NCT01152996 (10) [back to overview] | Change From Baseline in SDS Work/School Subscale |
NCT01153009 (6) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
NCT01153009 (6) [back to overview] | Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
NCT01153009 (6) [back to overview] | Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8 |
NCT01153009 (6) [back to overview] | Percentage of Participants in MADRS Remission at Week 8 |
NCT01153009 (6) [back to overview] | Percentage of Participants With a MADRS Response at Week 8 |
NCT01153009 (6) [back to overview] | Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20 |
NCT01163266 (6) [back to overview] | Percentage of Participants in MADRS Remission at Week 8 |
NCT01163266 (6) [back to overview] | Percentage of Participants With a MADRS Response at Week 8 |
NCT01163266 (6) [back to overview] | Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8 |
NCT01163266 (6) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
NCT01163266 (6) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
NCT01163266 (6) [back to overview] | Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20 |
NCT01179516 (6) [back to overview] | Percentage of Participants With a MADRS Response at Week 8 |
NCT01179516 (6) [back to overview] | Percentage of Participants in MADRS Remission at Week 8 |
NCT01179516 (6) [back to overview] | Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8 |
NCT01179516 (6) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score |
NCT01179516 (6) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
NCT01179516 (6) [back to overview] | Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥ 20 |
NCT01255787 (5) [back to overview] | Percentage of Participants With a MADRS Response at Week 8 |
NCT01255787 (5) [back to overview] | Percentage of Participants in MADRS Remission at Week 8 |
NCT01255787 (5) [back to overview] | Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8 |
NCT01255787 (5) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
NCT01255787 (5) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
NCT01299805 (12) [back to overview] | Maximum Concentration of 5-HT in Cerobrospinal Fluid |
NCT01299805 (12) [back to overview] | Maximum Concentration of 5-HIAA in Plasma |
NCT01299805 (12) [back to overview] | Maximum Concentration of 5-HIAA in Cerebrospinal Fluid |
NCT01299805 (12) [back to overview] | Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma |
NCT01299805 (12) [back to overview] | Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma |
NCT01299805 (12) [back to overview] | Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid |
NCT01299805 (12) [back to overview] | Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid |
NCT01299805 (12) [back to overview] | Maximum Concentration of 5-HT in Plasma |
NCT01299805 (12) [back to overview] | Time to Maximum Concentration of 5-HT in Plasma |
NCT01299805 (12) [back to overview] | Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid |
NCT01299805 (12) [back to overview] | Time to Maximum Concentration of 5-HIAA in Plasma |
NCT01299805 (12) [back to overview] | Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid |
NCT01323478 (10) [back to overview] | Number of Patients With Adverse Events (AEs) |
NCT01323478 (10) [back to overview] | Risk of Suicidality Using C-SSRS Scores |
NCT01323478 (10) [back to overview] | Change From Baseline in CGI-S Score After 52 Weeks of Treatment |
NCT01323478 (10) [back to overview] | Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment |
NCT01323478 (10) [back to overview] | Change From Baseline in MADRS Total Score After 52 Weeks of Treatment |
NCT01323478 (10) [back to overview] | Percentage of Patients Who Withdrew Due to Intolerance to Treatment |
NCT01323478 (10) [back to overview] | Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) |
NCT01323478 (10) [back to overview] | ASEX Total Score After 52 Weeks of Treatment |
NCT01323478 (10) [back to overview] | Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) |
NCT01323478 (10) [back to overview] | SDS Total Score After 52 Weeks of Treatment |
NCT01355081 (6) [back to overview] | Percentage of Patients With MADRS Response After 8 Weeks of Treatment |
NCT01355081 (6) [back to overview] | Percentage of Patients With MADRS Remission After 8 Weeks of Treatment |
NCT01355081 (6) [back to overview] | Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment |
NCT01355081 (6) [back to overview] | Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment |
NCT01355081 (6) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment |
NCT01355081 (6) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment |
NCT01364649 (3) [back to overview] | Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed |
NCT01364649 (3) [back to overview] | Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed |
NCT01364649 (3) [back to overview] | Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8 |
NCT01422213 (18) [back to overview] | Risk of Suicidality Using C-SSRS Scores |
NCT01422213 (18) [back to overview] | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline |
NCT01422213 (18) [back to overview] | Proportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10) |
NCT01422213 (18) [back to overview] | Clinical Status Using CGI-I Score at Week 8 |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-score |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in CGI-S Score |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function) |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in DSST (Number of Correct Symbols) |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-score |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function) |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in MADRS Total Score |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in RAVLT (Acquisition) |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in RAVLT (Delayed Recall) |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in the CRT (Attention) |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in the SRT (Speed of Processing) |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in the TMT A (Speed of Processing) |
NCT01422213 (18) [back to overview] | Change From Baseline to Week 8 in the TMT B (Executive Function) |
NCT01488071 (14) [back to overview] | Change From Baseline in MADRS Total Score at Week 8 |
NCT01488071 (14) [back to overview] | Change From Baseline in MADRS Total Score at Week 12 |
NCT01488071 (14) [back to overview] | Change From Baseline in HAM-A Total Score at Week 8 |
NCT01488071 (14) [back to overview] | Change From Baseline in HAM-A Total Score at Week 12 |
NCT01488071 (14) [back to overview] | Change From Baseline in CGI-S Score at Week 8 |
NCT01488071 (14) [back to overview] | Change From Baseline in CGI-S Score at Week 12 |
NCT01488071 (14) [back to overview] | Change From Baseline in SDS Total Score at Week 8 |
NCT01488071 (14) [back to overview] | Change in Clinical Status Using CGI-I Score at Week 12 |
NCT01488071 (14) [back to overview] | Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10) |
NCT01488071 (14) [back to overview] | Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10) |
NCT01488071 (14) [back to overview] | Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
NCT01488071 (14) [back to overview] | Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
NCT01488071 (14) [back to overview] | Change in Clinical Status Using CGI-I Score at Week 8 |
NCT01488071 (14) [back to overview] | Change From Baseline in SDS Total Score at Week 12 |
NCT01491035 (7) [back to overview] | t½ of Vortioxetine |
NCT01491035 (7) [back to overview] | Cmax of Vortioxetine |
NCT01491035 (7) [back to overview] | Oral Clearance (CL/F) of Vortioxetine |
NCT01491035 (7) [back to overview] | t½ of Lu AA34443 |
NCT01491035 (7) [back to overview] | Cmax of Lu AA34443 |
NCT01491035 (7) [back to overview] | AUC(0-24h) of Lu AA34443 |
NCT01491035 (7) [back to overview] | AUC(0-24h) of Vortioxetine |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the Trail Making Test B (TMT-B) |
NCT01564862 (15) [back to overview] | Change in Time From Baseline to Week 8 in the Stroop Test |
NCT01564862 (15) [back to overview] | Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the Detection Task (DT) |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST) |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT) |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the Identification Task (IT) |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the One-Back Task |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score |
NCT01564862 (15) [back to overview] | Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression |
NCT01564862 (15) [back to overview] | Percentage of Participants in MADRS Remission at Week 8 |
NCT01564862 (15) [back to overview] | Percentage of Participants With MADRS Response at Week 8 |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the MADRS Total Score |
NCT01564862 (15) [back to overview] | Change From Baseline to Week 8 in the Trail Making Test (TMT-A) |
NCT01571453 (6) [back to overview] | Change From Baseline in MADRS Total Score at Week 8 |
NCT01571453 (6) [back to overview] | Change in CGI-S Score From Baseline to Week 8 |
NCT01571453 (6) [back to overview] | Change in HAM-A Total Score From Baseline to Week 8 |
NCT01571453 (6) [back to overview] | MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline) |
NCT01571453 (6) [back to overview] | Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10) |
NCT01571453 (6) [back to overview] | CGI-I Score at Week 8 |
NCT02170220 (11) [back to overview] | AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine Metabolite Lu AA34443 |
NCT02170220 (11) [back to overview] | AUC(0-inf)u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine |
NCT02170220 (11) [back to overview] | AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine |
NCT02170220 (11) [back to overview] | AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA34443 |
NCT02170220 (11) [back to overview] | AUC(0-tlqc)u: Area Under the Unbound Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine |
NCT02170220 (11) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Vortioxetine |
NCT02170220 (11) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA34443 |
NCT02170220 (11) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA39835 |
NCT02170220 (11) [back to overview] | Cmaxu: Maximum Observed Unbound Plasma Concentration for Vortioxetine |
NCT02170220 (11) [back to overview] | AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA39835 |
NCT02170220 (11) [back to overview] | AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine |
NCT02234362 (14) [back to overview] | Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5) |
NCT02234362 (14) [back to overview] | Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5) |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Subscales - Emotional Control |
NCT02327013 (42) [back to overview] | Change in AISRS Inattention Sub-score |
NCT02327013 (42) [back to overview] | Change in Adult ADHD Self-Report Scale (ASRS) Total Score |
NCT02327013 (42) [back to overview] | Change in Adult ADHD Quality of Life Measure (AAQoL) Total Score |
NCT02327013 (42) [back to overview] | Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score |
NCT02327013 (42) [back to overview] | Change in AAQoL Subscales - Relationships Sub-score |
NCT02327013 (42) [back to overview] | Change in AAQoL Subscales - Psychological Health Sub-score |
NCT02327013 (42) [back to overview] | Change in AAQoL Subscales - Life Productivity Sub-score |
NCT02327013 (42) [back to overview] | Change in AAQoL Subscales - Life Outlook Sub-score |
NCT02327013 (42) [back to overview] | Change BRIEF-A Subscales - Initiate |
NCT02327013 (42) [back to overview] | Change in Perceived Deficits Questionnaire - Depression (PDQ-D) Total Score |
NCT02327013 (42) [back to overview] | Change AISRS Hyperactivity/Impulsivity Sub-score |
NCT02327013 (42) [back to overview] | Response (Defined as a CGI-I Score of 1 or 2), Stage 1 |
NCT02327013 (42) [back to overview] | Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score |
NCT02327013 (42) [back to overview] | Percentage of Patients Responding (Response Defined as 30% or Greater Reduction From Baseline in AISRS Total Score) |
NCT02327013 (42) [back to overview] | Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score |
NCT02327013 (42) [back to overview] | Inattention/Meta-cognition: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Using Metacognition Index |
NCT02327013 (42) [back to overview] | Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score |
NCT02327013 (42) [back to overview] | Clinical Global Impression - Global Improvement (CGI-I) Score |
NCT02327013 (42) [back to overview] | Change in WLQ Using the Global Productivity Index |
NCT02327013 (42) [back to overview] | Change in WLQ Domain Scores - Physical Demands |
NCT02327013 (42) [back to overview] | Change in WLQ Domain Scores - Output Demands |
NCT02327013 (42) [back to overview] | Change in WLQ Domain Scores - Mental-Interpersonal Work Demands |
NCT02327013 (42) [back to overview] | Change in WLQ Domain Scores - Limitations Handling Time |
NCT02327013 (42) [back to overview] | Change in SDS Item Scores - Work |
NCT02327013 (42) [back to overview] | Change in SDS Item Scores - Social Life |
NCT02327013 (42) [back to overview] | Change in SDS Item Scores - Number of Underproductive Days |
NCT02327013 (42) [back to overview] | Change in SDS Item Scores - Number of Days Lost |
NCT02327013 (42) [back to overview] | Change in SDS Item Scores - Family |
NCT02327013 (42) [back to overview] | Change in PDQ-D Subscales - Attention and Concentration Sub-score |
NCT02327013 (42) [back to overview] | Change in PDQ-D Sub-scales - Retrospective Memory Sub-score |
NCT02327013 (42) [back to overview] | Change in PDQ-D Sub-scales - Prospective Memory Sub-score |
NCT02327013 (42) [back to overview] | Change in PDQ-D Sub-scales - Planning and Organisation Sub-score |
NCT02327013 (42) [back to overview] | Change in Clinical Global Impression - Severity of Illness (CGI-S) Score |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Using the Behavioural Regulation Index |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Subscales - Working Memory |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Subscales - Task Monitor |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Subscales - Shift |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Subscales - Self Monitor |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Subscales - Planning/Organize |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Subscales - Organization of Materials |
NCT02327013 (42) [back to overview] | Change in BRIEF-A Subscales - Inhibit |
NCT02371980 (5) [back to overview] | Clinical Global Impression Scale-Global Improvement Scale (CGI-I) Score |
NCT02371980 (5) [back to overview] | Time From Randomization to Relapse of Major Depressive Disorder During the Entire 32-Week Double-Blind Treatment Period |
NCT02371980 (5) [back to overview] | Time From Randomization to Relapse of Major Depressive Disorder During the First 28 Weeks of the 32-Week Double-Blind Treatment Period |
NCT02371980 (5) [back to overview] | Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at Each Week Assessed |
NCT02371980 (5) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
NCT02389816 (9) [back to overview] | Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 (LOCF) |
NCT02389816 (9) [back to overview] | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Week 8 |
NCT02389816 (9) [back to overview] | Change From Baseline in Sheehan Disability Scale (SDS) Total Score to Week 8 (LOCF) |
NCT02389816 (9) [back to overview] | MADRS Remission at Week 8 (LOCF) |
NCT02389816 (9) [back to overview] | MADRS Response at Week 8 (Last Observation Carried Forward (LOCF)) |
NCT02389816 (9) [back to overview] | Change From Baseline in Perceived Deficits Questionnaire (PDQ-5) Total Score to Week 8 (LOCF) |
NCT02389816 (9) [back to overview] | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score to Week 8 (LOCF) |
NCT02389816 (9) [back to overview] | Change From Baseline in Digit Symbol Substitution Test (DSST) Total Score to Week 8 (LOCF) |
NCT02389816 (9) [back to overview] | Change From Baseline in Hamilton Depression Scale (HAM-D17) Total Score to Week 8 (LOCF) |
NCT02528409 (9) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating |
NCT02528409 (9) [back to overview] | Change in Number of Binge Eating Episodes |
NCT02528409 (9) [back to overview] | BMI |
NCT02528409 (9) [back to overview] | Clinical Global Impression Improvement Scale (CGI) |
NCT02528409 (9) [back to overview] | Hamilton Anxiety Rating Scale |
NCT02528409 (9) [back to overview] | Hamilton Depression Rating Scale |
NCT02528409 (9) [back to overview] | Number of Participants With 4-week Cessation From Binge Eating |
NCT02528409 (9) [back to overview] | Quality of Life Inventory |
NCT02528409 (9) [back to overview] | Three-Factor Eating Questionnaire |
NCT02637895 (4) [back to overview] | Change Clinician Administered PTSD Scale Score |
NCT02637895 (4) [back to overview] | Change in Depressive Symptoms in PTSD |
NCT02637895 (4) [back to overview] | Number of Participants That Achieve Treatment Response Via CGI-I |
NCT02637895 (4) [back to overview] | Number of Participants That Achieve Treatment Response Via Clinician Administered PTSD Scale (CAPS)-5 |
NCT02709655 (21) [back to overview] | Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Clinical Global Impression - Global Improvement (CGI-I) Score |
NCT02709655 (21) [back to overview] | Parent Global Assessment (PGA) Score |
NCT02709655 (21) [back to overview] | Percentage of Participants With CDRS-R Remission |
NCT02709655 (21) [back to overview] | Percentage of Participants With CGI-S Remission |
NCT02709655 (21) [back to overview] | Percentage of Participants With CDRS-R Response |
NCT02709655 (21) [back to overview] | Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 3, 4, 6, and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in General Behaviour Inventory (GBI) Depression Subscale Score, Using the 10-Item Depression Subscale Assessed by Parent (PGBI-10D) and Child (CGBI-10D) at Weeks 2, 4, 6, and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B |
NCT02709655 (21) [back to overview] | Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B |
NCT02709746 (28) [back to overview] | Change in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Scores |
NCT02709746 (28) [back to overview] | Change in PedsQL VAS: Tired (Fatigue) Score |
NCT02709746 (28) [back to overview] | Change in PedsQL VAS: Worry Score |
NCT02709746 (28) [back to overview] | Change General Behaviour Inventory (GBI) Depression Subscale Score Assessed by the Child |
NCT02709746 (28) [back to overview] | Change in CDRS-R Behaviour Score |
NCT02709746 (28) [back to overview] | Change in CDRS-R Somatic Score |
NCT02709746 (28) [back to overview] | Change in PQ-LES-Q Overall Score |
NCT02709746 (28) [back to overview] | Change in Symbol Digit Modalities Test (SDMT) |
NCT02709746 (28) [back to overview] | Clinical Global Impression - Global Improvement (CGI-I) Score |
NCT02709746 (28) [back to overview] | Parent Global Assessment-Global Improvement (PGA) Score |
NCT02709746 (28) [back to overview] | Change in CDRS-R Subjective Score |
NCT02709746 (28) [back to overview] | Change in CDRS-R Total Score During Treatment (at Week 4) |
NCT02709746 (28) [back to overview] | Change in CDRS-R Total Score During Treatment (at Week 2) |
NCT02709746 (28) [back to overview] | Change in CDRS-R Total Score During Treatment (at Week 6) |
NCT02709746 (28) [back to overview] | CDRS-R Remission |
NCT02709746 (28) [back to overview] | CDRS-R Response |
NCT02709746 (28) [back to overview] | Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment |
NCT02709746 (28) [back to overview] | Change in Children's Global Assessment Scale (CGAS) Score |
NCT02709746 (28) [back to overview] | Change in Clinical Global Impression Severity of Illness (CGI-S) Score |
NCT02709746 (28) [back to overview] | Change in CDRS-R Mood Score |
NCT02709746 (28) [back to overview] | Change in General Behaviour Inventory (GBI) Depression Sub Scale Score Assessed by the Parents |
NCT02709746 (28) [back to overview] | Change in PedsQL Emotional Distress Summary Average Score |
NCT02709746 (28) [back to overview] | CGI-S Remission |
NCT02709746 (28) [back to overview] | Change in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score |
NCT02709746 (28) [back to overview] | Change in PedsQL VAS Total Average Score |
NCT02709746 (28) [back to overview] | Change in PedsQL VAS: Angry Score |
NCT02709746 (28) [back to overview] | Change in PedsQL VAS: Pain or Hurt Score |
NCT02709746 (28) [back to overview] | Change in PedsQL VAS: Sad or Blue (Sadness) Score |
NCT02749721 (10) [back to overview] | Correlations Between BNA Latency Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores |
NCT02749721 (10) [back to overview] | Changes in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-16-SR) From Baseline to 8 Week Endpoint |
NCT02749721 (10) [back to overview] | Changes in Hamilton Depression Rating Scale (HDRS) 28 From Baseline to 8 Week Endpoint |
NCT02749721 (10) [back to overview] | Changes in Hamilton Depression Rating Scale (HDRS) 17 From Baseline to 8 Week Endpoint |
NCT02749721 (10) [back to overview] | Changes in Clinical Global Impression Scale (CGI-S) From Baseline to 8 Week Endpoint |
NCT02749721 (10) [back to overview] | Change in Montgomery and Asberg Depression Rating Scale (MADRS) |
NCT02749721 (10) [back to overview] | Change From Baseline to Endpoint in Digital Symbol Substitution Test. |
NCT02749721 (10) [back to overview] | BNA Scores Latencies |
NCT02749721 (10) [back to overview] | Correlations Between BNA Amplitude Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores |
NCT02749721 (10) [back to overview] | BNA Scores Amplitudes |
NCT02871297 (12) [back to overview] | Clinical Global Impression - Global Improvement (CGI-I) Score |
NCT02871297 (12) [back to overview] | Adolescents (12-18 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Self-report (BRIEF-SR) Using the GEC Score at Week 26 |
NCT02871297 (12) [back to overview] | Number of Participants With Response to the Palatability Questionnaire |
NCT02871297 (12) [back to overview] | Number of Participants With Response to the Acceptability Questionnaire |
NCT02871297 (12) [back to overview] | Children (7-11 Years): Change From Baseline in BRIEF-P Using the MI Score at Week 26 |
NCT02871297 (12) [back to overview] | Children (7-11 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Preschool (BRIEF-P) Using the Global Executive Composite (GEC) Score at Week 26 |
NCT02871297 (12) [back to overview] | Change From Baseline in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scale (PedsQL VAS) Total Score at Week 26 |
NCT02871297 (12) [back to overview] | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26 |
NCT02871297 (12) [back to overview] | Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Week 26 |
NCT02871297 (12) [back to overview] | Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26 |
NCT02871297 (12) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT02871297 (12) [back to overview] | Adolescents (12-18 Years): Change From Baseline in BRIEF-SR Using the MI Score at Week 26 |
NCT02932904 (9) [back to overview] | Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) |
NCT02932904 (9) [back to overview] | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) |
NCT02932904 (9) [back to overview] | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) |
NCT02932904 (9) [back to overview] | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 |
NCT02932904 (9) [back to overview] | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 |
NCT02932904 (9) [back to overview] | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 |
NCT02932904 (9) [back to overview] | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 |
NCT02932904 (9) [back to overview] | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 |
NCT02932904 (9) [back to overview] | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 |
NCT02969876 (3) [back to overview] | Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C) |
NCT02969876 (3) [back to overview] | Rey Auditory Verbal Learning Test |
NCT02969876 (3) [back to overview] | Digital Symbol Substitution Test |
NCT02972632 (8) [back to overview] | Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12 |
NCT02972632 (8) [back to overview] | Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12 |
NCT02972632 (8) [back to overview] | Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12 |
NCT02972632 (8) [back to overview] | Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12 |
NCT02972632 (8) [back to overview] | Change From Baseline in Clinical Global Impression Scale Severity (CGI-S) at Week 12 |
NCT02972632 (8) [back to overview] | Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12 |
NCT02972632 (8) [back to overview] | Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12 |
NCT02972632 (8) [back to overview] | Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 12 |
NCT03053362 (7) [back to overview] | Cognition Measured Using the THINC-it Tool |
NCT03053362 (7) [back to overview] | Changes in the World Health Organization Wellbeing Index (5-Item) |
NCT03053362 (7) [back to overview] | Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS) |
NCT03053362 (7) [back to overview] | Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score |
NCT03053362 (7) [back to overview] | Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B) |
NCT03053362 (7) [back to overview] | Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST) |
NCT03053362 (7) [back to overview] | Changes in Changes in Anhedonia From Baseline to Week 8 |
NCT03272711 (3) [back to overview] | Change in Total Fluid Cognitive Score |
NCT03272711 (3) [back to overview] | Change in Total Fluid Cognitive Score |
NCT03272711 (3) [back to overview] | Participant Function |
NCT03437564 (12) [back to overview] | AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Unchanged Lu AA21004 |
NCT03437564 (12) [back to overview] | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004 |
NCT03437564 (12) [back to overview] | Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004 |
NCT03437564 (12) [back to overview] | MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration of Unchanged Lu AA21004 |
NCT03437564 (12) [back to overview] | λz: Apparent Elimination Rate Constant of Unchanged Lu AA21004 |
NCT03437564 (12) [back to overview] | Number of Participants With TEAE Related to Clinical Laboratory Tests (Alanine Aminotransferase Increased) |
NCT03437564 (12) [back to overview] | Tmax: Time to Reach Cmax (Observed Value) of Unchanged Lu AA21004 |
NCT03437564 (12) [back to overview] | MRT∞, ev: Mean Residence Time 0 to Infinity of Unchanged Lu AA21004 |
NCT03437564 (12) [back to overview] | Number of Participants With TEAE Related to Vital Sign |
NCT03437564 (12) [back to overview] | Number of Participants With TEAE Related to 12-lead Electrocardiograms |
NCT03437564 (12) [back to overview] | Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) |
NCT03437564 (12) [back to overview] | T1/2z: Apparent Elimination Half-Life of Unchanged Lu AA21004 |
Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. (NCT00596817)
Timeframe: Double-blind Baseline and Week 24 of the double-blind period
Intervention | units on a scale (Mean) |
---|
Placebo | 0.89 |
Vortioxetine: 5 or 10 mg | -0.23 |
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Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT00596817)
Timeframe: Within first 24 weeks of the double-blind period
Intervention | percentage of patients who relapsed (Number) |
---|
Placebo | 26.0 |
Vortioxetine: 5 or 10 mg | 13.2 |
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Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
(NCT00596817)
Timeframe: Within 64 weeks of the double-blind period
Intervention | percentage of patients who relapsed (Number) |
---|
Placebo | 30.2 |
Vortioxetine: 5 or 10 mg | 15.2 |
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Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)
(NCT00596817)
Timeframe: Week 24 of the double-blind period (Counted From Open-label Baseline)
Intervention | percentage of patients (Number) |
---|
Placebo | 91.7 |
Vortioxetine: 5 or 10 mg | 98.0 |
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Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment
The Hamilton Depression Scale - 17 items (HAM-D-17) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 52. The higher the score, the more severe. (NCT00596817)
Timeframe: Double-blind Baseline and Week 24 of the double-blind period
Intervention | units on a scale (Mean) |
---|
Placebo | 1.61 |
Vortioxetine: 5 or 10 mg | 0.30 |
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Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment
(NCT00596817)
Timeframe: Double-blind Baseline and Week 24 of the double-blind period
Intervention | units on a scale (Mean) |
---|
Placebo | 1.45 |
Vortioxetine: 5 or 10 mg | -0.62 |
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Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. (NCT00596817)
Timeframe: Week 24 of the double-blind period (Counted From Double-blind Baseline)
Intervention | units on a scale (Mean) |
---|
Placebo | 0.14 |
Vortioxetine: 5 or 10 mg | -0.53 |
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Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)
(NCT00596817)
Timeframe: Week 24 of the double-blind period
Intervention | percentage of patients (Number) |
---|
Placebo | 82.6 |
Vortioxetine: 5 or 10 mg | 94.7 |
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Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT00596817)
Timeframe: Double-blind Baseline and Week 24 of the double-blind period
Intervention | units on a scale (Mean) |
---|
Placebo | 0.24 |
Vortioxetine: 5 or 10 mg | -0.14 |
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Change in Clinical Status Using CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. (NCT00635219)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | 2.52 |
Vortioxetine 2.5 mg | 2.32 |
Vortioxetine 5 mg | 2.32 |
Vortioxetine 10 mg | 2.35 |
Duloxetine 60 mg | 2.31 |
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Change From Baseline in ASEX Total Score After 8 Weeks of Treatment
"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction." (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -0.41 |
Vortioxetine 2.5 mg | -0.53 |
Vortioxetine 5 mg | -0.66 |
Vortioxetine 10 mg | -0.62 |
Duloxetine 60 mg | -0.38 |
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Change From Baseline in CGI-S Score After 8 Weeks of Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -1.64 |
Vortioxetine 2.5 mg | -1.83 |
Vortioxetine 5 mg | -1.81 |
Vortioxetine 10 mg | -1.83 |
Duloxetine 60 mg | -1.82 |
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Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -9.57 |
Vortioxetine 2.5 mg | -9.87 |
Vortioxetine 5 mg | -10.7 |
Vortioxetine 10 mg | -10.6 |
Duloxetine 60 mg | -11.0 |
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Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -14.8 |
Vortioxetine 2.5 mg | -16.2 |
Vortioxetine 5 mg | -16.5 |
Vortioxetine 10 mg | -16.3 |
Duloxetine 60 mg | -16.8 |
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Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -13.3 |
Vortioxetine 2.5 mg | -14.4 |
Vortioxetine 5 mg | -15.0 |
Vortioxetine 10 mg | -14.9 |
Duloxetine 60 mg | -15.7 |
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Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20
(NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -14.7 |
Vortioxetine 2.5 mg | -14.3 |
Vortioxetine 5 mg | -15.8 |
Vortioxetine 10 mg | -15.8 |
Duloxetine 60 mg | -17.3 |
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Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
(NCT00635219)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|
Placebo | 46.9 |
Vortioxetine 2.5 mg | 54.2 |
Vortioxetine 5 mg | 56.1 |
Vortioxetine 10 mg | 57.6 |
Duloxetine 60 mg | 57.1 |
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Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
(NCT00635219)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|
Placebo | 33.8 |
Vortioxetine 2.5 mg | 32.9 |
Vortioxetine 5 mg | 36.1 |
Vortioxetine 10 mg | 35.8 |
Duloxetine 60 mg | 34.9 |
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Change From Baseline in SDS Total Score After 8 Weeks of Treatment
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. (NCT00635219)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -6.11 |
Vortioxetine 2.5 mg | -7.10 |
Vortioxetine 5 mg | -6.52 |
Vortioxetine 10 mg | -7.81 |
Duloxetine 60 mg | -7.91 |
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Clinical Global Impression Scale-Global Improvement Scale
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=142, 143, 149, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (149, 146, 153, 149) | Week 6 (149, 146, 153, 149) | Week 8 (n=149, 146, 153, 149) |
---|
Duloxetine 60 mg | 3.31 | 2.99 | 2.73 | 2.50 | 2.39 |
,Placebo | 3.54 | 3.21 | 2.97 | 2.83 | 2.79 |
,Vortioxetine 2.5 mg | 3.42 | 3.17 | 2.93 | 2.82 | 2.73 |
,Vortioxetine 5 mg | 3.46 | 3.10 | 2.87 | 2.74 | 2.63 |
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Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00672620)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to depression | Baseline: Any sick leave | Baseline: Sick leave related to depression | Week 8: Any resource use | Week 8: Any hospitalization-related service | Week 8: Hospitalization related to depression | Week 8: Any sick leave | Week 8: Sick leave related to depression |
---|
Duloxetine 60 mg | 42 | 3 | 0 | 14 | 11 | 27 | 2 | 1 | 5 | 2 |
,Placebo | 40 | 4 | 2 | 18 | 13 | 21 | 1 | 0 | 5 | 2 |
,Vortioxetine 2.5 mg | 51 | 1 | 1 | 11 | 9 | 19 | 0 | 0 | 5 | 4 |
,Vortioxetine 5 mg | 42 | 0 | 0 | 11 | 10 | 20 | 1 | 0 | 9 | 3 |
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Percentage of Responders in HAM-D 24 Total Score by Study Visit
A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | Week 8 (n=149, 146, 153, 149) |
---|
Duloxetine 60 mg | 10.2 | 22.1 | 34.9 | 47.0 | 51.0 |
,Placebo | 9.2 | 15.4 | 26.2 | 32.9 | 32.2 |
,Vortioxetine 2.5 mg | 8.4 | 17.1 | 30.8 | 37.7 | 41.1 |
,Vortioxetine 5 mg | 8.7 | 17.6 | 24.2 | 37.3 | 37.9 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | Week 8 (n=149, 146, 153, 149) |
---|
Duloxetine 60 mg | -2.30 | -3.94 | -4.88 | -6.15 | -6.56 |
,Placebo | -2.63 | -3.82 | -5.12 | -5.84 | -5.75 |
,Vortioxetine 2.5 mg | -2.98 | -4.41 | -5.10 | -5.77 | -5.91 |
,Vortioxetine 5 mg | -2.55 | -3.76 | -4.25 | -4.89 | -5.29 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -6.83 |
Vortioxetine 2.5 mg | -6.46 |
Vortioxetine 5 mg | -6.59 |
Duloxetine 60 mg | -8.91 |
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Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate. (NCT00672620)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -10.50 |
Vortioxetine 2.5 mg | -12.04 |
Vortioxetine 5 mg | -11.08 |
Duloxetine 60 mg | -13.47 |
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Percentage of Participants in MADRS Remission at Week 8
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT00672620)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 22.8 |
Vortioxetine 2.5 mg | 28.8 |
Vortioxetine 5 mg | 23.5 |
Duloxetine 60 mg | 37.6 |
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Percentage of Participants With a Sustained Response in HAM-D24
A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8. (NCT00672620)
Timeframe: Baseline to Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 12.1 |
Vortioxetine 2.5 mg | 15.8 |
Vortioxetine 5 mg | 17.0 |
Duloxetine 60 mg | 21.5 |
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Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)
The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 4 and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=141, 142, 149, 146) | Week 4 (148, 145, 152, 149) | Week 8 (n=148, 145, 152, 149) |
---|
Duloxetine 60 mg | -2.88 | -4.89 | -5.70 |
,Placebo | -2.51 | -4.02 | -4.25 |
,Vortioxetine 2.5 mg | -2.43 | -3.65 | -3.98 |
,Vortioxetine 5 mg | -2.74 | -3.69 | -4.04 |
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Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) |
---|
Duloxetine 60 mg | -5.66 | -8.42 | -10.88 | -12.78 |
,Placebo | -5.12 | -7.19 | -9.39 | -10.43 |
,Vortioxetine 2.5 mg | -5.44 | -7.95 | -9.94 | -11.21 |
,Vortioxetine 5 mg | -5.28 | -7.99 | -8.96 | -10.97 |
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Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | Week 8 (n=149, 146, 153, 149) |
---|
Duloxetine 60 mg | -0.44 | -0.75 | -1.12 | -1.39 | -1.56 |
,Placebo | -0.28 | -0.63 | -0.92 | -1.11 | -1.14 |
,Vortioxetine 2.5 mg | -0.40 | -0.65 | -0.92 | -1.08 | -1.21 |
,Vortioxetine 5 mg | -0.37 | -0.66 | -0.90 | -1.08 | -1.17 |
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Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672620)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=142, 143, 150, 147) | Week 2 (n=149, 146, 153, 149) | Week 4 (n=149, 146, 153, 149) | Week 6 (n=149, 146, 153, 149) | Week 8 (149, 146, 153, 149) |
---|
Duloxetine 60 mg | -5.49 | -8.95 | -11.34 | -13.29 | -14.10 |
,Placebo | -4.90 | -7.57 | -9.66 | -11.04 | -11.22 |
,Vortioxetine 2.5 mg | -5.16 | -7.71 | -9.58 | -11.25 | -11.61 |
,Vortioxetine 5 mg | -5.06 | -7.81 | -9.35 | -11.27 | -11.30 |
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Percentage of Responders in HAM-D24 Total Score by Study Visit
A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. (NCT00672958)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5 and 6.
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=281, 286) | Week 2 (n=286, 291) | Week 3 (n=286, 292) | Week 4 (n=286, 292) | Week 5 (n=286, 292) | Week 6 (n=286, 292) |
---|
Placebo | 7.8 | 23.8 | 31.8 | 39.2 | 44.4 | 46.2 |
,Vortioxetine | 7.0 | 21.0 | 32.9 | 37.0 | 43.8 | 46.2 |
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Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00672958)
Timeframe: Baseline and Week 6
Intervention | participants (Number) |
---|
| Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to depression | Baseline: Any sick leave | Baseline: Sick leave related to depression | Week 6: Any resource use | Week 6: Any hospitalization-related service | Week 6: Hospitalization related to depression | Week 6: Any sick leave | Week 6: Sick leave related to depression |
---|
Placebo | 82 | 1 | 1 | 16 | 9 | 58 | 3 | 0 | 7 | 3 |
,Vortioxetine | 77 | 0 | 0 | 21 | 13 | 41 | 1 | 0 | 7 | 2 |
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Clinical Global Impression Scale-Global Improvement Scale
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate. (NCT00672958)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5 and 6.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=281, 286) | Week 2 (n=286, 291) | Week 3 (n=286, 292) | Week 4 (n=286, 292) | Week 5 (n=286, 292) | Week 6 (n=286, 292) |
---|
Placebo | 3.38 | 3.09 | 2.90 | 2.74 | 2.74 | 2.61 |
,Vortioxetine | 3.46 | 3.08 | 2.84 | 2.75 | 2.65 | 2.57 |
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Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672958)
Timeframe: Baseline and Weeks 1, 2, 3, 4 and 5
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=281, 286) | Week 2 (n= 286, 291) | Week 3 (n= 286, 292) | Week 4 (n= 286, 292) | Week 5 (n=286, 292) |
---|
Placebo | -6.03 | -9.30 | -11.05 | -12.33 | -13.11 |
,Vortioxetine | -5.96 | -9.05 | -11.73 | -12.66 | -13.98 |
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Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)
The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672958)
Timeframe: Baseline and Weeks 1, 4 and 6.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=279, 286) | Week 4 (n=284, 292) | Week 6 (n=284, 292) |
---|
Placebo | -2.81 | -4.18 | -4.56 |
,Vortioxetine | -2.73 | -4.05 | -4.97 |
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Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least square means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672958)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5 and 6.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=281, 286) | Week 2 (n=286, 291) | Week 3 (n=286, 292) | Week 4 (n=286, 292) | Week 5 (n=286, 292) | Week 6 (n=286, 292) |
---|
Placebo | -6.88 | -10.57 | -12.48 | -13.72 | -14.40 | -15.48 |
,Vortioxetine | -6.38 | -9.82 | -12.76 | -13.70 | -15.12 | -15.80 |
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Change From Baseline in Hamilton Anxiety Scale (HAM-A)
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least squares means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672958)
Timeframe: Baseline and Weeks 1, 2, 4 and 6.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=281, 286) | Week 2 (n=286, 291) | Week 4 (n=286, 292) | Week 6 (n=286, 292) |
---|
Placebo | -3.25 | -4.92 | -6.52 | -7.60 |
,Vortioxetine | -3.21 | -4.77 | -6.88 | -7.84 |
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Change From Baseline in Clinical Global Impression Scale-Severity of Illness
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672958)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5 and 6.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=281, 286) | Week 2 (n=286, 291) | Week 3 (n=286, 292) | Week 4 (n=286, 292) | Week 5 (n=286, 292) | Week 6 (n=286, 292) |
---|
Placebo | -0.47 | -0.82 | -1.07 | -1.25 | -1.28 | -1.46 |
,Vortioxetine | -0.40 | -0.82 | -1.08 | -1.20 | -1.36 | -1.46 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00672958)
Timeframe: Baseline and Week 6
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -6.61 |
Vortioxetine | -6.69 |
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Percentage of Participants With a Sustained Response in HAM-D24
A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 5 and at least 50% decrease from Baseline at Week 6. (NCT00672958)
Timeframe: Baseline to Week 6
Intervention | percentage of participants (Number) |
---|
Placebo | 21.0 |
Vortioxetine | 19.5 |
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Percentage of Participants in MADRS Remission at Week 6
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT00672958)
Timeframe: Week 6
Intervention | percentage of participants (Number) |
---|
Placebo | 32.2 |
Vortioxetine | 29.1 |
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Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate. (NCT00672958)
Timeframe: Baseline and Week 6
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -13.87 |
Vortioxetine | -14.61 |
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Change From Baseline in CGI-S Score After 52 Weeks of Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT00694304)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | -1.00 |
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Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. (NCT00694304)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | -5.44 |
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Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. (NCT00694304)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | -6.86 |
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Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT00694304)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | -7.35 |
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Change From Baseline in SDS Total Score After 52 Weeks of Treatment
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. (NCT00694304)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | -5.60 |
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Percentage of Patients Who Withdrew Due to Intolerance to Treatment
(NCT00694304)
Timeframe: Baseline to Week 52
Intervention | percentage of patients (Number) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | 7.7 |
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Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment
(NCT00694304)
Timeframe: Baseline and Week 52
Intervention | percentage of patients (Number) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | 2.74 |
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Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
(NCT00694304)
Timeframe: Week 52
Intervention | percentage of patients (Mean) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | 83.0 |
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Number of Patients With Adverse Events (AEs)
(NCT00694304)
Timeframe: Baseline to end of the 4-week safety follow-up period
Intervention | participants (Number) |
---|
| Patients With AEs | Patients With SAEs | Patients With AEs Leading to Withdrawal |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | 391 | 18 | 42 |
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Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
(NCT00694304)
Timeframe: Week 52
Intervention | percentage of patients (Mean) |
---|
Vortioxetine 2.5, 5, or 10 mg/Day | 94.2 |
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Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00707980)
Timeframe: Baseline and Week 52
Intervention | participants (Number) |
---|
| Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to depression | Baseline: Any sick leave | Baseline: Sick leave related to depression | Week 52: Any resource use | Week 52:Any hospitalization-related services | Final Visit: Hospitalization related to depression | Week 52: Any sick leave | Week 52: Sick leave related to depression |
---|
Vortioxetine | 137 | 4 | 0 | 53 | 42 | 138 | 7 | 0 | 41 | 25 |
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Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval [QTc]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula. (NCT00707980)
Timeframe: Weeks 4, 12, 24, 36 and 52
Intervention | participants (Number) |
---|
| Heart rate ≤50 bpm and change ≤-15bpm | Heart rate ≥120 bpm and change ≥15 bpm | RR interval <500 msec and change ≤-200 msec | RR interval >1200 msec and change ≥200 msec | PR interval <120 msec | PR interval ≥250 msec | QT interval <280 msec | QT interval >500 msec | QTcB <340 msec | QTcB >500 msec | QTcB Change <-60 msec | QTcB Change >60 msec | QTcF <340 msec | QTcF >500 msec | QTcF Change <-60 msec | QTcF Change >60 msec |
---|
Vortioxetine | 9 | 0 | 0 | 13 | 31 | 2 | 0 | 2 | 0 | 3 | 6 | 4 | 0 | 2 | 3 | 2 |
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Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal. (NCT00707980)
Timeframe: Weeks 4, 8, 12, 20, 28, 36, 44 and 52
Intervention | participants (Number) |
---|
| Alanine aminotransferase (ALT) ≥ 3 X ULN | Aspartate aminotransferase (AST) ≥ 3 X ULN | Bilirubin ≥ 34.2 μmol/L | Cholesterol ≥ 7.8 mmol/L | Creatine kinase ≥ 2 X ULN | Creatinine ≥ 175 μmol/L | Glucose ≤ 2.8 mmol/L | Glucose ≥ 13.9 mmol/L | High density lipoprotein cholesterol < 0.9 mmol/L | Low density lipoprotein cholesterol ≥ 5.0 mmol/L | Potassium ≤ 3.0 mmol/L | Potassium ≥ 5.5 mmol/L | Sodium ≤ 125 mmol/L | Sodium ≥ 155 mmol/L | Triglycerides ≥ 3.40 mmol/L | Urate ≤ 0.7 X LLN | Urate ≥ 1.3 XULN | Eosinophils ≥ 0.6 10^9/L | Erythrocytes ≤ 0.9 X LLN | Erythrocytes ≥ 1.1 X ULN | Hematocrit ≤ 0.9 X LLN | Hemoglobin ≤ 0.9 X LLN | Leukocytes ≤ 2.8 X 10^9/L | Leukocytes ≥ 16 X 10^9/L | Lymphocytes ≤ 0.6 X 10^9/L | Lymphocytes ≥ 7 X 10^9/L | Neutrophils ≤ 1.4 X 10^9/L | Neutrophils ≥ 15 X 10^9/L |
---|
Vortioxetine | 3 | 6 | 1 | 49 | 80 | 1 | 9 | 7 | 102 | 69 | 0 | 45 | 1 | 1 | 168 | 4 | 12 | 24 | 9 | 1 | 16 | 41 | 10 | 3 | 5 | 0 | 26 | 2 |
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Number of Participants With Potentially Clinically Significant Vital Sign Findings
Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure. (NCT00707980)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52
Intervention | participants (Number) |
---|
| SSBP ≤90 mmHg and decrease of ≥20 mmHg | SSBP ≥180 mmHg and increase of ≥20 mmHg | SDBP ≤50 mmHg and decrease of ≥15 mmHg | SDBP ≥105 mmHg and increase of ≥15 mmHg | Supine pulse rate ≤50 bpm and decrease of ≥15 bpm | Supine pulse rate ≥120 bpm and increase of ≥15 bpm | Weight Change of ≥7% weight |
---|
Vortioxetine | 7 | 4 | 1 | 8 | 7 | 2 | 155 |
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Physical Examination Findings
"Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area.~Each system was assessed as normal or abnormal." (NCT00707980)
Timeframe: Baseline and Week 52
Intervention | participants (Number) |
---|
| Appearance at Baseline: Normal | Appearance at Baseline: Abnormal | Appearance at Week 52: Normal | Appearance at Week 52: Abnormal | Extremities at Baseline: Normal | Extremities at Baseline: Abnormal | Extremities at Week 52: Normal | Extremities at Week 52: Abnormal | Skin at Baseline: Normal | Skin at Baseline: Abnormal | Skin at Week 52: Normal | Skin at Week 52: Abnormal | Head-Neck at Baseline: Normal | Head-Neck at Baseline: Abnormal | Head-Neck at Week 52: Normal | Head-Neck at Week 52: Abnormal | Eyes-Ears-Nose-Throat at Baseline: Normal | Eyes-Ears-Nose-Throat at Baseline: Abnormal | Eyes-Ears-Nose-Throat at Week 52: Normal | Eyes-Ears-Nose-Throat at Week 52: Abnormal | Lungs-Chest at Baseline: Normal | Lungs-Chest at Baseline: Abnormal | Lungs-Chest at Week 52: Normal | Lungs-Chest at Week 52: Abnormal | Heart/Cardiovascular at Baseline: Normal | Heart/Cardiovascular at Baseline: Abnormal | Heart/Cardiovascular at Week 52: Normal | Heart/Cardiovascular at Week 52: Abnormal | Abdomen at Baseline: Normal | Abdomen at Baseline: Abnormal | Abdomen at Baseline: Not done | Abdomen at Week 52: Normal | Abdomen at Week 52: Abnormal | Abdomen at Week 52: Not done | Musculoskeletal at Baseline: Normal | Musculoskeletal at Baseline: Abnormal | Musculoskeletal at Week 52: Normal | Musculoskeletal at Week 52: Abnormal |
---|
Vortioxetine | 758 | 76 | 484 | 40 | 806 | 28 | 511 | 13 | 730 | 104 | 465 | 59 | 822 | 12 | 518 | 6 | 772 | 62 | 485 | 39 | 827 | 7 | 523 | 1 | 816 | 18 | 512 | 12 | 818 | 12 | 4 | 515 | 8 | 1 | 790 | 44 | 493 | 31 |
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Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks. (NCT00707980)
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.
Intervention | scores on a scale (Mean) |
---|
| Week 1 (n=805) | Week 2 (n=822) | Week 4 (n=805) | Week 8 (n=752) | Week 12 (n=715) | Week 16 (n=671) | Week 20 (n=639) | Week 24 (n=613) | Week 28 (n=599) | Week 36 (n=568) | Week 44 (n=540) | Week 52 (n=522) | Final Visit (n=829) |
---|
Vortioxetine | -1.1 | -3.1 | -4.7 | -6.5 | -7.0 | -7.7 | -8.4 | -8.3 | -8.9 | -9.3 | -9.6 | -10.0 | -7.9 |
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Change From Baseline to the Final Visit in the Sheehan Disability Scale
The Sheehan Disability Scale (SDS) assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. (NCT00707980)
Timeframe: Baseline and Week 52
Intervention | scores on a scale (Mean) |
---|
Vortioxetine | -4.6 |
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Number of Participants With Adverse Events (AEs)
"The intensity (severity) of each AE was defined as:~Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities.~Moderate: sufficiently uncomfortable to produce some impairment of normal activities.~Severe: incapacitating, preventing the patient from participating in normal activities.~The causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion." (NCT00707980)
Timeframe: From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)
Intervention | participants (Number) |
---|
| Any adverse event | Related adverse event | Not related adverse event | Mild adverse event | Moderate adverse event | Severe adverse event | Adverse event leading to early termination | Serious adverse event | Serious related adverse event | Serious not related adverse event | Serious adverse event leading to early termination | Deaths |
---|
Vortioxetine | 589 | 413 | 176 | 187 | 320 | 82 | 50 | 29 | 5 | 33 | 11 | 0 |
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Change From Baseline in the Clinical Global Impression of Severity of Illness Scale
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks. (NCT00707980)
Timeframe: Baseline and Weeks 4, 24 and 52
Intervention | scores on a scale (Mean) |
---|
| Week 4 (n=818) | Week 24 (n=642) | Week 52 (n= 527) | Final Visit (n=818) |
---|
Vortioxetine | -0.53 | -0.98 | -1.33 | -1.00 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks. (NCT00707980)
Timeframe: Baseline and Weeks 4, 24 and 52
Intervention | scores on a scale (Mean) |
---|
| Week 4 (n=818) | Week 24 (n=642) | Week 52 (n=527) | Final Visit (n= 818) |
---|
Vortioxetine | -2.9 | -5.1 | -6.6 | -5.2 |
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Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks. (NCT00707980)
Timeframe: Baseline and Weeks 4, 24 and 52
Intervention | scores on a scale (Mean) |
---|
| Week 4 (n=818) | Week 24 (n=642) | Week 52 (n=526) | Final Visit (n=818) |
---|
Vortioxetine | -4.5 | -7.9 | -9.5 | -7.4 |
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Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed
The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=151, 148, 141, 149, 141) | Week 2 (n=147, 145, 142, 147, 129) | Week 4 (n=140, 135, 132, 134, 116) | Week 6 (n=127, 123, 121, 120, 112) |
---|
Duloxetine 60 mg | 3.36 | 2.76 | 2.44 | 2.25 |
,Placebo | 3.44 | 3.03 | 2.81 | 2.61 |
,Vortioxetine 10 mg | 3.40 | 2.96 | 2.68 | 2.41 |
,Vortioxetine 2.5 mg | 3.46 | 3.08 | 2.67 | 2.53 |
,Vortioxetine 5 mg | 3.41 | 2.90 | 2.67 | 2.43 |
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Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00730691)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to anxiety | Baseline: Any sick leave | Baseline: Sick leave related to anxiety | Week 8: Any resource use | Week 8: Any hospitalization-related service | Week 8: Hospitalization related to anxiety | Week 8: Any sick leave | Week 8: Sick leave related to anxiety |
---|
Duloxetine 60 mg | 38 | 2 | 0 | 12 | 7 | 22 | 3 | 1 | 11 | 4 |
,Placebo | 34 | 0 | 0 | 14 | 5 | 26 | 0 | 0 | 13 | 2 |
,Vortioxetine 10 mg | 43 | 0 | 0 | 15 | 9 | 23 | 1 | 0 | 7 | 1 |
,Vortioxetine 2.5 mg | 36 | 3 | 2 | 16 | 10 | 24 | 0 | 0 | 6 | 2 |
,Vortioxetine 5 mg | 26 | 1 | 1 | 13 | 9 | 29 | 0 | 0 | 7 | 3 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=63, 76, 70, 70, 66) | Week 2 (n=62, 73, 70, 68, 62) | Week 4 (n=60, 68, 67, 63, 54) | Week 6 (n=58, 63, 62, 54, 51) |
---|
Duloxetine 60 mg | -6.78 | -10.40 | -12.56 | -14.35 |
,Placebo | -5.32 | -7.55 | -8.61 | -10.72 |
,Vortioxetine 10 mg | -5.94 | -8.51 | -10.98 | -12.75 |
,Vortioxetine 2.5 mg | -6.07 | -8.82 | -11.61 | -12.86 |
,Vortioxetine 5 mg | -5.96 | -10.18 | -12.87 | -14.11 |
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Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 2 and 4
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=116, 111, 109, 125, 112) | Week 2 (n=116, 114, 116, 123, 103) | Week 4 (n=108, 106, 106, 115, 91) |
---|
Duloxetine 60 mg | -4.74 | -7.09 | -7.95 |
,Placebo | -3.22 | -4.53 | -4.55 |
,Vortioxetine 10 mg | -4.11 | -5.46 | -6.47 |
,Vortioxetine 2.5 mg | -2.74 | -4.18 | -4.98 |
,Vortioxetine 5 mg | -3.28 | -5.02 | -5.92 |
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Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed
The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 4 and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=150, 149, 141, 149, 141) | Week 4 (n=141, 142, 139, 141, 126) | Week 8 (n=123, 120, 119, 111, 108) |
---|
Duloxetine 60 mg | -1.19 | -2.62 | -2.77 |
,Placebo | -0.81 | -1.32 | -2.21 |
,Vortioxetine 10 mg | -1.25 | -1.61 | -1.94 |
,Vortioxetine 2.5 mg | -0.83 | -1.83 | -1.82 |
,Vortioxetine 5 mg | -0.88 | -1.70 | -1.96 |
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Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed
The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1 and 4
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=150, 149, 141, 149, 141) | Week 4 (n=141, 142, 139, 141, 126) |
---|
Duloxetine 60 mg | -2.91 | -5.11 |
,Placebo | -1.81 | -3.24 |
,Vortioxetine 10 mg | -2.22 | -4.01 |
,Vortioxetine 2.5 mg | -1.85 | -3.34 |
,Vortioxetine 5 mg | -1.89 | -3.60 |
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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n= 151, 149, 142, 149, 143) | Week 2 (n=147, 145, 143, 147, 130) | Week 4 (n= 139, 135, 132, 133, 116) | Week 6 (n= 127, 123, 122, 120, 112) |
---|
Duloxetine 60 mg | -5.48 | -9.29 | -11.13 | -12.66 |
,Placebo | -4.70 | -7.30 | -8.66 | -10.28 |
,Vortioxetine 10 mg | -5.04 | -7.63 | -9.73 | -11.05 |
,Vortioxetine 2.5 mg | -4.56 | -7.28 | -9.77 | -10.82 |
,Vortioxetine 5 mg | -4.90 | -8.22 | -9.84 | -11.26 |
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Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Weeks 1, 2, 4, 6 and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=151, 148, 141, 149, 142) | Week 2 (n=147, 145, 142, 147, 130) | Week 4 (n=140, 135, 132, 134, 115) | Week 6 (n=127, 123, 121, 120, 112) | Week 8 (n=120, 118, 114, 111, 106) |
---|
Duloxetine 60 mg | -0.54 | -0.97 | -1.28 | -1.55 | -1.77 |
,Placebo | -0.42 | -0.71 | -0.95 | -1.22 | -1.42 |
,Vortioxetine 10 mg | -0.42 | -0.75 | -1.11 | -1.35 | -1.44 |
,Vortioxetine 2.5 mg | -0.37 | -0.74 | -1.12 | -1.32 | -1.50 |
,Vortioxetine 5 mg | -0.39 | -0.80 | -1.02 | -1.31 | -1.38 |
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Percentage of Responders in HAM-A Total Score at Week 8
Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00730691)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 42.2 |
Vortioxetine 2.5 mg | 44.8 |
Vortioxetine 5 mg | 42.6 |
Vortioxetine 10 mg | 44.8 |
Duloxetine 60 mg | 51.0 |
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Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8
The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | 2.47 |
Vortioxetine 2.5 mg | 2.36 |
Vortioxetine 5 mg | 2.38 |
Vortioxetine 10 mg | 2.38 |
Duloxetine 60 mg | 2.03 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -11.61 |
Vortioxetine 2.5 mg | -14.12 |
Vortioxetine 5 mg | -13.87 |
Vortioxetine 10 mg | -13.22 |
Duloxetine 60 mg | -16.15 |
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Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -11.27 |
Vortioxetine 2.5 mg | -12.23 |
Vortioxetine 5 mg | -11.57 |
Vortioxetine 10 mg | -11.66 |
Duloxetine 60 mg | -13.87 |
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Change From Baseline in Sheehan Disability Scale (SDS) at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -6.35 |
Vortioxetine 2.5 mg | -6.15 |
Vortioxetine 5 mg | -6.68 |
Vortioxetine 10 mg | -7.95 |
Duloxetine 60 mg | -8.81 |
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Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8
The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors. (NCT00730691)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -4.00 |
Vortioxetine 2.5 mg | -3.89 |
Vortioxetine 5 mg | -4.24 |
Vortioxetine 10 mg | -5.09 |
Duloxetine 60 mg | -5.54 |
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Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00730691)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=151, 149, 142, 149, 143) | Week 2 (n=154, 154, 147, 154, 149) | Week 4 (n=154, 154, 148, 154, 149) | Week 6 (n=154, 154, 148, 154, 149) |
---|
Duloxetine 60 mg | 16.8 | 28.9 | 42.3 | 47.7 |
,Placebo | 11.3 | 20.8 | 26.0 | 36.4 |
,Vortioxetine 10 mg | 10.1 | 21.4 | 35.1 | 40.9 |
,Vortioxetine 2.5 mg | 6.7 | 20.1 | 30.5 | 37.7 |
,Vortioxetine 5 mg | 8.5 | 21.1 | 32.4 | 40.5 |
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Percentage of Participants in HAM-A Remission at Each Week Assessed
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00730691)
Timeframe: Weeks 1, 2, 4, 6 and 8
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=151, 149, 142, 149, 143) | Week 2 (n=154, 154, 147, 154, 149) | Week 4 (n=154, 154, 148, 154, 149) | Week 6 (n=154, 154, 148, 154, 149) | Week 8 (n=154, 154, 148, 154, 149) |
---|
Duloxetine 60 mg | 4.9 | 12.1 | 17.4 | 20.8 | 28.2 |
,Placebo | 4.0 | 6.5 | 10.4 | 16.2 | 22.1 |
,Vortioxetine 10 mg | 2.0 | 3.9 | 13.0 | 16.9 | 20.1 |
,Vortioxetine 2.5 mg | 2.0 | 8.4 | 13.6 | 14.9 | 20.1 |
,Vortioxetine 5 mg | 0.7 | 7.5 | 11.5 | 14.9 | 19.6 |
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Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model adjusting for Baseline CGI-S score, center, and treatment. (NCT00731120)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=146, 141, 143) | Week 2 (n=148, 143, 146) | Week 4 (n=148, 144, 146) | Week 6 (n=148, 144, 146) | Week 8 (n=148, 144, 146) |
---|
Placebo | 3.35 | 2.99 | 2.87 | 2.68 | 2.60 |
,Vortioxetine 10 mg | 3.38 | 2.92 | 2.69 | 2.60 | 2.51 |
,Vortioxetine 2.5 mg | 3.30 | 2.91 | 2.75 | 2.58 | 2.56 |
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Change From Baseline in Sheehan Disability Scale (SDS) at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00731120)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -4.26 |
Vortioxetine 2.5 mg | -5.73 |
Vortioxetine 10 mg | -5.24 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00731120)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -9.87 |
Vortioxetine 2.5 mg | -10.75 |
Vortioxetine 10 mg | -10.68 |
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Percentage of Participants in HAM-A Remission at Week 8
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00731120)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 21.6 |
Vortioxetine 2.5 mg | 21.5 |
Vortioxetine 10 mg | 19.2 |
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Percentage of Responders in HAM-A Total Score at Week 8
Response was defined as a participant with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00731120)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 41.9 |
Vortioxetine 2.5 mg | 46.5 |
Vortioxetine 10 mg | 41.8 |
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Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model adjusting for Baseline score, center, and treatment. (NCT00731120)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=146, 140, 143) | Week 2 (n=148, 143, 146) | Week 4 (n=148, 144, 146) | Week 6 (n=148, 144, 146) | Week 8 (n=148, 144, 146) |
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Placebo | -0.40 | -0.68 | -0.82 | -0.93 | -1.10 |
,Vortioxetine 10 mg | -0.37 | -0.69 | -0.93 | -1.03 | -1.14 |
,Vortioxetine 2.5 mg | -0.47 | -0.82 | -1.01 | -1.14 | -1.21 |
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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00731120)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=147, 142, 143) | Week 2 (n=148, 144, 146) | Week 4 (n=148, 144, 146) | Week 6 (n=148, 144, 146) |
---|
Placebo | -5.07 | -7.41 | -8.88 | -9.54 |
,Vortioxetine 10 mg | -5.30 | -8.05 | -9.54 | -10.50 |
,Vortioxetine 2.5 mg | -5.29 | -8.11 | -9.45 | -10.35 |
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Change From Baseline in Hospital Anxiety and Depression (HAD) Scales
The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. (NCT00731120)
Timeframe: Baseline and Weeks 1, 4 and 8.
Intervention | scores on a scale (Mean) |
---|
| Anxiety Scale at Week 1 (n=147, 142, 143) | Anxiety Scale at Week 4 (n=148, 144, 146) | Anxiety Scale at Week 8 (n=148, 144, 146) | Depression Scale at Week 1 (n=147, 142, 143) | Depression Scale at Week 4 (n=148, 144, 146) | Depression Scale at Week 8 (n=148, 144, 146) |
---|
Placebo | -1.64 | -2.81 | -3.63 | -0.71 | -1.66 | -1.76 |
,Vortioxetine 10 mg | -2.03 | -3.39 | -4.20 | -1.15 | -2.10 | -2.21 |
,Vortioxetine 2.5 mg | -2.07 | -3.66 | -4.29 | -1.35 | -2.23 | -2.56 |
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Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00731120)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to anxiety | Baseline: Any sick leave | Baseline: Sick leave related to anxiety | Week 8: Any resource use | Week 8: Any hospitalization-related service | Week 8: Hospitalization related to anxiety | Week 8: Any sick leave | Week 8: Sick leave related to anxiety |
---|
Placebo | 32 | 2 | 1 | 5 | 4 | 14 | 3 | 0 | 5 | 1 |
,Vortioxetine 10 mg | 32 | 1 | 0 | 10 | 4 | 19 | 1 | 0 | 8 | 1 |
,Vortioxetine 2.5 mg | 34 | 1 | 0 | 13 | 8 | 23 | 0 | 0 | 6 | 4 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -6.68 |
Vortioxetine 5 mg | -6.35 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -13.16 |
Vortioxetine 5 mg | -12.57 |
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Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8
The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -4.84 |
Vortioxetine 5 mg | -5.06 |
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Clinical Global Impression Scale-Global Improvement at Week 8
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | 2.25 |
Vortioxetine 5 mg | 2.25 |
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Percentage of Responders in HAM-A Total Score at Week 8
Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00734071)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 50.0 |
Vortioxetine 5 mg | 53.1 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -14.04 |
Vortioxetine 5 mg | -14.05 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means and P-values were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Weeks 1, 2 and 4
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=117, 116) | Week 2 (n=109, 114) | Week 4 (n=106, 108) |
---|
Placebo | -2.13 | -4.35 | -5.57 |
,Vortioxetine 5 mg | -2.46 | -4.02 | -5.38 |
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Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00734071)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=141, 144) | Week 2 (n=144, 145) | Week 4 (n=144, 145) | Week 6 (n=144, 145) |
---|
Placebo | 9.9 | 22.9 | 34.7 | 47.2 |
,Vortioxetine 5 mg | 6.9 | 24.1 | 37.2 | 45.5 |
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Percentage of Participants in HAM-A Remission at Each Week Assessed
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00734071)
Timeframe: Weeks 1, 2, 4, 6 and 8
Intervention | percentage of participants (Number) |
---|
| Week 1 (n-141, 144) | Week 2 (n=144, 145) | Week 4 (n=144, 145) | Week 6 (n=144, 145) | Week 8 (n=144, 145) |
---|
Placebo | 2.1 | 5.6 | 15.3 | 22.2 | 22.2 |
,Vortioxetine 5 mg | 0.7 | 7.6 | 12.4 | 22.1 | 25.5 |
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Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00734071)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to anxiety | Baseline: Any sick leave | Baseline: Sick leave related to anxiety | Week 8: Any resource use | Week 8: Any hospitalization-related service | Week 8: Hospitalization related to anxiety | Week 8: Any sick leave | Week 8: Sick leave related to anxiety |
---|
Placebo | 30 | 1 | 0 | 8 | 7 | 22 | 0 | 0 | 4 | 2 |
,Vortioxetine 5 mg | 30 | 0 | 0 | 10 | 4 | 19 | 1 | 0 | 6 | 1 |
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Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=141, 144) | Week 2 (n=134, 142) | Week 4 (n=131, 135) | Week 6 (n=124, 129) |
---|
Placebo | 3.32 | 2.92 | 2.57 | 2.42 |
,Vortioxetine 5 mg | 3.38 | 2.83 | 2.57 | 2.39 |
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Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed
The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Weeks 1, 4 and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=139, 142) | Week 4 (n=130, 135) | Week 8 (n=111, 124) |
---|
Placebo | -1.02 | -1.84 | -2.55 |
,Vortioxetine 5 mg | -1.09 | -2.28 | -2.62 |
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Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed
The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Weeks 1 and 4
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=139, 142) | Week 4 (n=130, 135) |
---|
Placebo | -1.81 | -3.41 |
,Vortioxetine 5 mg | -2.07 | -3.72 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=71, 71) | Week 2 (n=70, 70) | Week 4 (n=67, 67) | Week 6 (n=63, 65) |
---|
Placebo | -5.39 | -8.37 | -10.90 | -13.60 |
,Vortioxetine 5 mg | -4.73 | -8.94 | -10.74 | -12.82 |
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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Weeks 1, 2, 4 and 6.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=141, 144) | Week 2 (n=134, 142) | Week 4 (n=131, 135) | Week 6 (n=124, 129) |
---|
Placebo | -4.84 | -7.78 | -10.13 | -12.39 |
,Vortioxetine 5 mg | -4.59 | -8.22 | -9.82 | -11.61 |
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Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM). (NCT00734071)
Timeframe: Baseline to Weeks 1, 2, 4, 6 and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=141, 144) | Week 2 (n=134, 142) | Week 4 (n=131, 135) | Week 6 (n=124, 129) | Week 8 (n=113, 124) |
---|
Placebo | -0.37 | -0.75 | -1.15 | -1.45 | -1.72 |
,Vortioxetine 5 mg | -0.38 | -0.86 | -1.05 | -1.40 | -1.54 |
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Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline and Weeks 1, 2, 4, 6, and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=139, 137, 138, 138) | Week 2 (n=138, 138, 135, 135) | Week 4 (n=135, 133, 135, 127) | Week 6 (n=134, 130, 129, 126) | Week 8 (n=128, 124, 129, 122) |
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Placebo | -0.24 | -0.46 | -0.75 | -0.96 | -1.12 |
,Vortioxetine 1 mg | -0.20 | -0.58 | -1.07 | -1.41 | -1.50 |
,Vortioxetine 10 mg | -0.24 | -0.60 | -1.06 | -1.55 | -1.74 |
,Vortioxetine 5 mg | -0.22 | -0.61 | -1.10 | -1.38 | -1.63 |
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Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=66, 70, 62, 75) | Week 2 (n=65, 70, 59, 72) | Week 4 (n=64, 68, 60, 69) | Week 6 (n=64, 67, 57, 68) |
---|
Placebo | -3.79 | -5.76 | -8.56 | -10.25 |
,Vortioxetine 1 mg | -2.94 | -7.21 | -11.41 | -13.68 |
,Vortioxetine 10 mg | -3.19 | -7.74 | -12.06 | -15.10 |
,Vortioxetine 5 mg | -3.55 | -6.58 | -10.20 | -13.23 |
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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline and Weeks 1, 2, 4, 6, and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=139, 137, 138, 138) | Week 2 (n=138, 138, 135, 135) | Week 4 (n=135, 133, 135, 127) | Week 6 (n=134, 130, 129, 126) | Week 8 (n=128, 124, 129, 122) |
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Placebo | -1.58 | -3.06 | -4.54 | -5.44 | -5.98 |
,Vortioxetine 1 mg | -1.27 | -3.72 | -5.95 | -7.29 | -8.08 |
,Vortioxetine 10 mg | -1.56 | -3.77 | -6.11 | -8.33 | -8.86 |
,Vortioxetine 5 mg | -1.41 | -3.09 | -5.60 | -7.21 | -8.11 |
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Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed
The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis (NCT00735709)
Timeframe: Baseline and Weeks 1, 4, and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Anxiety Scale at Week 1 (n=139, 137, 138, 137) | Anxiety Scale at Week 4 (n=137, 138, 135, 134) | Anxiety Scale at Week 8 (n=129, 129, 127, 122) | Depression Scale at Week 1 (n=139, 137, 138, 137) | Depression Scale at Week 4 (n=137, 138, 135, 134) | Depression Scale at Week 8 (n=129, 129, 127, 122) |
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Placebo | -0.46 | -1.95 | -2.55 | -0.32 | -2.32 | -3.19 |
,Vortioxetine 1 mg | -1.14 | -2.83 | -3.79 | -0.90 | -3.45 | -4.67 |
,Vortioxetine 10 mg | -0.91 | -2.80 | -4.38 | -0.92 | -3.80 | -5.49 |
,Vortioxetine 5 mg | -0.87 | -2.81 | -3.70 | -0.74 | -3.32 | -5.02 |
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Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week
The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline and Weeks 1, 2, 4, 6, and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=139, 137, 138, 138) | Week 2 (n=138, 138, 135, 135) | Week 4 (n=135, 133, 135, 127) | Week 6 (n=134, 130, 129, 126) | Week 8 (n=128, 124, 129, 122) |
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Placebo | -2.90 | -4.92 | -7.85 | -9.72 | -10.91 |
,Vortioxetine 1 mg | -2.55 | -6.65 | -10.79 | -13.16 | -14.89 |
,Vortioxetine 10 mg | -2.57 | -6.51 | -10.89 | -14.19 | -15.65 |
,Vortioxetine 5 mg | -2.66 | -6.40 | -10.30 | -13.10 | -15.09 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline and Weeks 1, 2 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=104, 101, 105, 97) | Week 2 (n=102, 101, 100, 96) | Week 6 (n=99, 97, 97, 88) |
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Placebo | -1.22 | -2.53 | -5.95 |
,Vortioxetine 1 mg | -1.13 | -3.44 | -5.69 |
,Vortioxetine 10 mg | -1.43 | -3.40 | -8.27 |
,Vortioxetine 5 mg | -1.78 | -4.14 | -6.92 |
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Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=139, 137, 138, 138) | Week 2 (n=138, 138, 135, 135) | Week 4 (n=135, 133, 135, 127) | Week 6 (n=134, 130, 129, 126) |
---|
Placebo | -3.47 | -5.66 | -8.42 | -10.23 |
,Vortioxetine 1 mg | -2.81 | -7.27 | -11.09 | -13.35 |
,Vortioxetine 10 mg | -3.20 | -7.42 | -11.88 | -15.22 |
,Vortioxetine 5 mg | -3.20 | -7.27 | -11.00 | -13.67 |
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Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed
The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=139, 137, 138, 138) | Week 2 (n=138, 138, 135, 135) | Week 4 (n=135, 133, 135, 127) | Week 6 (n=134, 130, 129, 126) |
---|
Placebo | 3.65 | 3.40 | 3.03 | 2.95 |
,Vortioxetine 1 mg | 3.71 | 3.16 | 2.69 | 2.48 |
,Vortioxetine 10 mg | 3.64 | 3.23 | 2.78 | 2.37 |
,Vortioxetine 5 mg | 3.67 | 3.19 | 2.82 | 2.50 |
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Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -11.02 |
Vortioxetine 1 mg | -15.16 |
Vortioxetine 5 mg | -15.50 |
Vortioxetine 10 mg | -15.61 |
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Percentage of Responders in HAM-D24 Total Score at Week 8
A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. (NCT00735709)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 23.0 |
Vortioxetine 1 mg | 47.5 |
Vortioxetine 5 mg | 45.3 |
Vortioxetine 10 mg | 49.6 |
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Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants' absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00735709)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to depression | Baseline: Any sick leave | Baseline: Sick leave related to depression | Week 8: Any resource use | Week 8: Any hospitalization-related service | Week 8: Hospitalization related to depression | Week 8: Any sick leave | Week 8: Sick leave related to depression |
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Placebo | 62 | 4 | 3 | 17 | 12 | 31 | 3 | 0 | 16 | 13 |
,Vortioxetine 1 mg | 64 | 3 | 3 | 7 | 6 | 13 | 0 | 0 | 6 | 6 |
,Vortioxetine 10 mg | 61 | 4 | 2 | 21 | 18 | 25 | 2 | 0 | 18 | 14 |
,Vortioxetine 5 mg | 71 | 6 | 4 | 14 | 10 | 25 | 1 | 1 | 11 | 9 |
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Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8
The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -11.30 |
Vortioxetine 1 mg | -14.82 |
Vortioxetine 5 mg | -15.42 |
Vortioxetine 10 mg | -16.23 |
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Percentage of Participants in MADRS Remission at Other Weeks Assessed
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT00735709)
Timeframe: Weeks 1, 2, 4 and 6
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=139, 137, 138, 138) | Week 2 (n=139, 139, 139, 139) | Week 4 (n=139, 139, 139, 139) | Week 6 (n=139, 139, 139, 139) |
---|
Placebo | 0.7 | 2.2 | 6.5 | 10.1 |
,Vortioxetine 1 mg | 0.7 | 2.2 | 11.5 | 20.1 |
,Vortioxetine 10 mg | 0 | 1.4 | 10.8 | 22.3 |
,Vortioxetine 5 mg | 0 | 1.4 | 11.5 | 20.9 |
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Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed
A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. (NCT00735709)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=139, 137, 138, 138) | Week 2 (n=139, 139, 139, 139) | Week 4 (n=139, 139, 139, 139) | Week 6 (n=139, 139, 139, 139) |
---|
Placebo | 0.7 | 5.0 | 18.0 | 23.7 |
,Vortioxetine 1 mg | 0.7 | 7.9 | 27.3 | 38.1 |
,Vortioxetine 10 mg | 1.4 | 8.6 | 26.6 | 43.9 |
,Vortioxetine 5 mg | 0.7 | 7.2 | 24.5 | 36.0 |
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Percentage of Participants With a Sustained Response in HAM-D24 Total Score
A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8. (NCT00735709)
Timeframe: From Baseline through Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 10.1 |
Vortioxetine 1 mg | 9.4 |
Vortioxetine 5 mg | 10.1 |
Vortioxetine 10 mg | 10.8 |
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Percentage of Participants in MADRS Remission at Week 8
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT00735709)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 16.5 |
Vortioxetine 1 mg | 25.9 |
Vortioxetine 5 mg | 28.8 |
Vortioxetine 10 mg | 26.6 |
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Clinical Global Impression Scale-Global Improvement at Week 8
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | 2.84 |
Vortioxetine 1 mg | 2.37 |
Vortioxetine 5 mg | 2.37 |
Vortioxetine 10 mg | 2.29 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. (NCT00735709)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -6.54 |
Vortioxetine 1 mg | -6.58 |
Vortioxetine 5 mg | -7.65 |
Vortioxetine 10 mg | -8.08 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -6.14 |
Vortioxetine 5 mg | -8.10 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -10.49 |
Vortioxetine 5 mg | -14.30 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -10.44 |
Vortioxetine 5 mg | -15.55 |
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Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8
The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -4.20 |
Vortioxetine 5 mg | -6.49 |
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Clinical Global Impression Scale-Global Improvement at Week 8
The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | 2.66 |
Vortioxetine 5 mg | 2.19 |
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Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed
The Clinical Global Impression-Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Weeks 1, 2, 4, 6 and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=146, 148) | Week 2 (n=147, 144) | Week 4 (n=136, 137) | Week 6 (n=128, 129) | Week 8 (n=126, 128) |
---|
Placebo | -0.23 | -0.53 | -0.87 | -1.09 | -1.26 |
,Vortioxetine 5 mg | -0.19 | -0.60 | -1.04 | -1.40 | -1.78 |
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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Weeks 1, 2, 4 and 6.
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=146, 148) | Week 2 (n=147, 144) | Week 4 (n=136, 137) | Week 6 (n=128, 129) |
---|
Placebo | -2.46 | -5.05 | -7.43 | -9.17 |
,Vortioxetine 5 mg | -2.50 | -6.21 | -9.62 | -11.93 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Weeks 1, 2 and 4
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=121, 117) | Week 2 (n=122, 114) | Week 4 (n=112, 107) |
---|
Placebo | -1.32 | -2.93 | -4.35 |
,Vortioxetine 5 mg | -1.12 | -3.04 | -5.13 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=100, 95) | Week 2 (n=99, 92) | Week 4 (n=89, 89) | Week 6 (n=83, 83) |
---|
Placebo | -2.64 | -4.89 | -7.33 | -9.02 |
,Vortioxetine 5 mg | -2.62 | -6.43 | -10.08 | -12.90 |
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Percentage of Participants in HAM-A Remission at Each Week Assessed
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00744627)
Timeframe: Weeks 1, 2, 4, 6 and 8
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=146, 148) | Week 2 (n=148, 149) | Week 4 (n=148, 149) | Week 6 (n=148, 149) | Week 8 (n=148, 149) |
---|
Placebo | 0 | 2.7 | 6.8 | 12.2 | 17.6 |
,Vortioxetine 5 mg | 0 | 2.7 | 8.7 | 16.8 | 30.2 |
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Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00744627)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | percentage of participants (Number) |
---|
| Week 1 (n=146, 148) | Week 2 (n=148, 149) | Week 4 (n=148, 149) | Week 6 (n=148, 149) |
---|
Placebo | 2.7 | 12.2 | 20.3 | 29.7 |
,Vortioxetine 5 mg | 2.0 | 12.1 | 28.9 | 43.6 |
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Percentage of Responders in HAM-A Total Score at Week 8
Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). (NCT00744627)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 39.9 |
Vortioxetine 5 mg | 61.7 |
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Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed
The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Weeks 1, 4 and 8
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=146, 148) | Week 4 (n=140, 140) | Week 8 (n=128, 129) |
---|
Placebo | -0.18 | -1.08 | -1.50 |
,Vortioxetine 5 mg | -0.28 | -1.62 | -3.18 |
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Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed
The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Weeks 1 and 4
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=146, 148) | Week 4 (n=140, 140) |
---|
Placebo | -1.42 | -3.13 |
,Vortioxetine 5 mg | -1.14 | -4.07 |
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Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed
The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis. (NCT00744627)
Timeframe: Baseline to Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=146, 148) | Week 2 (n=147, 144) | Week 4 (n=136, 137) | Week 6 (n=128, 129) |
---|
Placebo | 3.58 | 3.31 | 2.99 | 2.74 |
,Vortioxetine 5 mg | 3.67 | 3.10 | 2.66 | 2.43 |
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Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. (NCT00744627)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| Baseline: Any resource use | Baseline: Any hospitalization-related services | Baseline: Hospitalization related to anxiety | Baseline: Any sick leave | Baseline: Sick leave related to anxiety | Week 8: Any resource use | Week 8: Any hospitalization-related service | Week 8: Hospitalization related to anxiety | Week 8: Any sick leave | Week 8: Sick leave related to anxiety |
---|
Placebo | 79 | 7 | 4 | 7 | 4 | 14 | 0 | 0 | 2 | 2 |
,Vortioxetine 5 mg | 84 | 3 | 2 | 7 | 4 | 25 | 1 | 0 | 4 | 3 |
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Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. (NCT00761306)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 5 or 10 mg/Day | -3.46 |
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Number of Patients With Adverse Events (AEs)
(NCT00761306)
Timeframe: Up to 52 weeks and a 4-week safety follow-up period
Intervention | participants (Number) |
---|
| Patients With AEs | Patients With SAEs | Patients With AEs Leading to Withdrawal | Patients With Baseline Events |
---|
Vortioxetine 5 or 10 mg/Day | 64 | 1 | 5 | 16 |
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Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
(NCT00761306)
Timeframe: Week 52
Intervention | percentage of patients (Number) |
---|
Vortioxetine 5 or 10 mg/Day | 92.7 |
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Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
(NCT00761306)
Timeframe: Week 52
Intervention | percentage of patients (Number) |
---|
Vortioxetine 5 or 10 mg/Day | 81.8 |
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Percentage of Patients Who Withdrew Due to Intolerance to Treatment
(NCT00761306)
Timeframe: Baseline to Week 52
Intervention | percentage of patients (Number) |
---|
Vortioxetine 5 or 10 mg/Day | 6.8 |
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Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT00761306)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 5 or 10 mg/Day | -4.33 |
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Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -5.74 |
Vortioxetine 5 mg | -8.09 |
Duloxetine 60 mg | -9.28 |
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Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment
(NCT00811252)
Timeframe: Baseline and Week 1
Intervention | units on a scale (Mean) |
---|
Placebo | -3.62 |
Vortioxetine 5 mg | -4.04 |
Duloxetine 60 mg | -3.48 |
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Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment
(NCT00811252)
Timeframe: Baseline and Week 2
Intervention | units on a scale (Mean) |
---|
Placebo | -6.66 |
Vortioxetine 5 mg | -6.95 |
Duloxetine 60 mg | -7.91 |
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Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
(NCT00811252)
Timeframe: Baseline and Week 4
Intervention | units on a scale (Mean) |
---|
Placebo | -8.99 |
Vortioxetine 5 mg | -10.1 |
Duloxetine 60 mg | -12.3 |
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Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
(NCT00811252)
Timeframe: Baseline and Week 6
Intervention | units on a scale (Mean) |
---|
Placebo | -10.2 |
Vortioxetine 5 mg | -12.3 |
Duloxetine 60 mg | -14.4 |
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Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -10.3 |
Vortioxetine 5 mg | -13.7 |
Duloxetine 60 mg | -15.8 |
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Change From Baseline in CGI-S Score After 8 Weeks of Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -1.03 |
Vortioxetine 5 mg | -1.63 |
Duloxetine 60 mg | -2.05 |
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Risk of Suicidality Using C-SSRS Scores
The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient. (NCT00811252)
Timeframe: Up to 8 weeks
Intervention | participants (Number) |
---|
| No ideation or behavior | Completed Suicide | Suicide Attempt | Preparatory Actions Toward Imminent Suicidal Behav | Suicidal Ideation: Passive | Suicidal Ideation: Active / Nonspecific | Suicidal Ideation: Active / Method, but no intent | Suicidal Ideation: Active / Method and intent, but | Suicidal Ideation: Active / Method, intent, and pl | Self-Injurious Behavior Without Suicidal Intent |
---|
Duloxetine 60 mg | 106 | 0 | 1 | 0 | 7 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 103 | 0 | 0 | 0 | 8 | 3 | 0 | 0 | 0 | 0 |
,Vortioxetine 5 mg | 107 | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 0 |
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Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)
(NCT00811252)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|
Placebo | 35 |
Vortioxetine 5 mg | 53 |
Duloxetine 60 mg | 63 |
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Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
(NCT00811252)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|
Placebo | 21 |
Vortioxetine 5 mg | 34 |
Duloxetine 60 mg | 47 |
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Change in Clinical Status Using CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. (NCT00811252)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | 2.91 |
Vortioxetine 5 mg | 2.35 |
Duloxetine 60 mg | 2.07 |
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Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -11.2 |
Vortioxetine 5 mg | -15.5 |
Duloxetine 60 mg | -18.0 |
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Change From Baseline in GDS Total Score After 8 Weeks of Treatment
The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity. (NCT00811252)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -0.65 |
Vortioxetine 5 mg | -1.08 |
Duloxetine 60 mg | -1.32 |
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Change From Baseline in MADRS Total Score After 1 Week of Treatment
(NCT00839423)
Timeframe: Baseline and Week 1
Intervention | units on a scale (Mean) |
---|
Placebo | -5.04 |
Vortioxetine 5 mg | -5.26 |
Vortioxetine 10 mg | -5.86 |
Venlafaxine 225 mg | -4.50 |
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Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. (NCT00839423)
Timeframe: Baseline and Week 6
Intervention | units on a scale (Mean) |
---|
Placebo | -8.41 |
Vortioxetine 5 mg | -11.71 |
Vortioxetine 10 mg | -11.41 |
Venlafaxine 225 mg | -11.29 |
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Change From Baseline in CGI-S Score After 6 Weeks of Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT00839423)
Timeframe: Baseline and Week 6
Intervention | units on a scale (Mean) |
---|
Placebo | -1.55 |
Vortioxetine 5 mg | -2.45 |
Vortioxetine 10 mg | -2.51 |
Venlafaxine 225 mg | -2.58 |
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Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
(NCT00839423)
Timeframe: Week 6
Intervention | percentage of patients (Number) |
---|
Placebo | 44.8 |
Vortioxetine 5 mg | 66.7 |
Vortioxetine 10 mg | 68.0 |
Venlafaxine 225 mg | 72.3 |
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Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
(NCT00839423)
Timeframe: Week 6
Intervention | percentage of patients (Number) |
---|
Placebo | 26.7 |
Vortioxetine 5 mg | 49.1 |
Vortioxetine 10 mg | 49.0 |
Venlafaxine 225 mg | 55.4 |
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Change in Clinical Status Using CGI-I Score at Week 6
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. (NCT00839423)
Timeframe: Week 6
Intervention | units on a scale (Mean) |
---|
Placebo | 2.64 |
Vortioxetine 5 mg | 2.05 |
Vortioxetine 10 mg | 2.04 |
Venlafaxine 225 mg | 1.96 |
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Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT00839423)
Timeframe: Baseline and Week 6
Intervention | units on a scale (Mean) |
---|
Placebo | -14.50 |
Vortioxetine 5 mg | -20.40 |
Vortioxetine 10 mg | -20.20 |
Venlafaxine 225 mg | -20.92 |
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Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe. (NCT00839423)
Timeframe: Baseline and Week 6
Intervention | units on a scale (Mean) |
---|
Placebo | -12.23 |
Vortioxetine 5 mg | -17.51 |
Vortioxetine 10 mg | -17.57 |
Venlafaxine 225 mg | -17.32 |
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Change From Baseline in ASEX Total Score After 8 Weeks of Treatment
"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction." (NCT01140906)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | 0.28 |
Vortioxetine 15 mg | -0.39 |
Vortioxetine 20 mg | -0.20 |
Duloxetine 60 mg | -1.25 |
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Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20
(NCT01140906)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -12.20 |
Vortioxetine 15 mg | -17.44 |
Vortioxetine 20 mg | -18.62 |
Duloxetine 60 mg | -20.91 |
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Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT01140906)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -11.70 |
Vortioxetine 15 mg | -17.23 |
Vortioxetine 20 mg | -18.79 |
Duloxetine 60 mg | -21.15 |
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Change From Baseline in SDS Total Score After 8 Weeks of Treatment
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. (NCT01140906)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -4.46 |
Vortioxetine 15 mg | -7.70 |
Vortioxetine 20 mg | -8.38 |
Duloxetine 60 mg | -11.39 |
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Change in Clinical Status Using CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. (NCT01140906)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | 2.86 |
Vortioxetine 15 mg | 2.18 |
Vortioxetine 20 mg | 1.92 |
Duloxetine 60 mg | 1.75 |
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Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine
The Discontinuation-Emergent Signs and Symptoms Scale (DESS) was designed to evaluate possible effects of discontinuation of antidepressant therapy. It is a clinician-rated instrument that queries for signs and symptoms on a 43-item checklist (for example, agitation, insomnia, fatigue, and dizziness) to assess whether the item (event) is discontinuation-emergent. A new or worsened event reported after discontinuation of therapy scores 1 point on the checklist, and the DESS total score is the sum of all positive scores on the checklist. A higher score indicates more symptoms. (NCT01140906)
Timeframe: Change from Week 8 in DESS total score analyzed at Week 10
Intervention | units on a scale (Mean) |
---|
Placebo | 0.15 |
Vortioxetine 15 mg | 0.01 |
Vortioxetine 20 mg | 0.72 |
Duloxetine 60 mg | 2.28 |
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Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
(NCT01140906)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|
Placebo | 19 |
Vortioxetine 15 mg | 35 |
Vortioxetine 20 mg | 38 |
Duloxetine 60 mg | 54 |
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Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
(NCT01140906)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|
Placebo | 32 |
Vortioxetine 15 mg | 57 |
Vortioxetine 20 mg | 62 |
Duloxetine 60 mg | 74 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score
The change between the SDS total score at each assessed visit and the total score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. (NCT01152996)
Timeframe: Baseline and Weeks 12, 24, 36, and 52
Intervention | units on a scale (Mean) |
---|
| Week 12 (n=650) | Week 24 (n=494) | Week 36 (n=414) | Week 52 (n=381) |
---|
Vortioxetine | -2.8 | -3.9 | -4.0 | -4.7 |
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Number of Participants With Serious Treatment-Emergent Adverse Events
Serious treatment-emergent adverse events (serious-TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A serious-TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered serious adverse events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned. (NCT01152996)
Timeframe: Over the 52 week period
Intervention | participants (Number) |
---|
Vortioxetine | 29 |
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Treatment-Emergent Adverse Events Leading to Study Discontinuation
Treatment-emergent adverse events are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. (NCT01152996)
Timeframe: Over the 52 week period
Intervention | participants (Number) |
---|
Vortioxetine | 117 |
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Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
"The change between CGI-S score at each assessed visit and CGI-S score at baseline. The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill). Higher scores indicate greater severity of illness." (NCT01152996)
Timeframe: Baseline and Weeks 4, 24, and 52
Intervention | units on a scale (Mean) |
---|
| Week 4 (n=1030) | Week 24 (n=743) | Week 52 (n=549) |
---|
Vortioxetine | -0.6 | -1.0 | -1.2 |
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Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The change between MADRS total score at each assessed visit and MADRS score at baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. (NCT01152996)
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52
Intervention | units on a scale (Mean) |
---|
| Week 1 (n=1043) | Week 2 (n=1043) | Week 4 (n=1004) | Week 8 (n=936) | Week 12 (n=843) | Week 16 (n=777) | Week 20 (n=747) | Week 24 (n=697) | Week 28 (n=670) | Week 36 (n=617) | Week 44 (n=573) | Week 52 (n=534) |
---|
Vortioxetine | -2.7 | -4.8 | -6.1 | -7.9 | -8.5 | -9.1 | -9.4 | -9.7 | -9.5 | -9.7 | -10.3 | -10.3 |
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Change From Baseline in SDS Family Life/Home Responsibilities Subscale
The change between the Sheehan Disability family life/home responsibilities subscale score at each assessed visit and family life/home responsibilities subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment. (NCT01152996)
Timeframe: Baseline and Weeks 12, 24, 36, and 52
Intervention | units on a scale (Mean) |
---|
| Week 12 (n=942) | Week 24 (n=721) | Week 36 (n=617) | Week 52 (n=545) |
---|
Vortioxetine | -0.9 | -1.3 | -1.4 | -1.6 |
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Change From Baseline in SDS Social Life Subscale
The change between the Sheehan Disability social life subscale score at each assessed visit and social life subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment. (NCT01152996)
Timeframe: Baseline and Weeks 12, 24, 36, and 52
Intervention | units on a scale (Mean) |
---|
| Week 12 (n=942) | Week 24 (n=721) | Week 36 (n=617) | Week 52 (n=545) |
---|
Vortioxetine | -1.0 | -1.4 | -1.4 | -1.6 |
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Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
The change between HAM-A score at each assessed visit and HAM-A score at baseline. HAM-A is a 14 item rating scale to quantify anxiety symptomatology severity (i.e., anxious mood, tension, fear, insomnia, etc.) rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56. Higher scores indicate greater severity of symptoms. (NCT01152996)
Timeframe: Baseline and Weeks 4, 24, and 52
Intervention | units on a scale (Mean) |
---|
| Week 4 (n=1029) | Week 24 (n=742) | Week 52 (n=548) |
---|
Vortioxetine | -2.6 | -4.2 | -4.8 |
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Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. (NCT01152996)
Timeframe: Over the 52 week period
Intervention | participants (Number) |
---|
| Nausea | Diarrhea | Vomiting | Constipation | Nasopharyngitis | Viral upper respiratory tract infection | Upper respiratory tract infection | Weight increased | Headache | Insomnia |
---|
Vortioxetine | 258 | 80 | 68 | 65 | 68 | 66 | 60 | 65 | 136 | 56 |
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Change From Baseline in SDS Work/School Subscale
The change between the Sheehan Disability work/school subscale score at each assessed visit and work/school subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment. (NCT01152996)
Timeframe: Baseline and Weeks 12, 24, 36, and 52
Intervention | units on a scale (Mean) |
---|
| Week 12 (n=650) | Week 24 (n=494) | Week 36 (n=414) | Week 52 (n=381) |
---|
Vortioxetine | -0.8 | -1.2 | -1.2 | -1.4 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects. (NCT01153009)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -7.68 |
Vortioxetine 15 mg | -7.73 |
Vortioxetine 20 mg | -8.55 |
Duloxetine 60 mg | -9.66 |
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Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects. (NCT01153009)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -12.83 |
Vortioxetine 15 mg | -14.30 |
Vortioxetine 20 mg | -15.57 |
Duloxetine 60 mg | -16.90 |
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Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8
The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects. (NCT01153009)
Timeframe: Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | 2.65 |
Vortioxetine 15 mg | 2.54 |
Vortioxetine 20 mg | 2.47 |
Duloxetine 60 mg | 2.31 |
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Percentage of Participants in MADRS Remission at Week 8
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01153009)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 26.8 |
Vortioxetine 15 mg | 26.9 |
Vortioxetine 20 mg | 29.3 |
Duloxetine 60 mg | 26.0 |
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Percentage of Participants With a MADRS Response at Week 8
Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01153009)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 39.2 |
Vortioxetine 15 mg | 44.1 |
Vortioxetine 20 mg | 44.2 |
Duloxetine 60 mg | 54.8 |
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Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20
"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity." (NCT01153009)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -14.27 |
Vortioxetine 15 mg | -13.34 |
Vortioxetine 20 mg | -14.89 |
Duloxetine 60 mg | -18.31 |
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Percentage of Participants in MADRS Remission at Week 8
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01163266)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 14.2 |
Vortioxetine 10 mg | 21.4 |
Vortioxetine 20 mg | 22.3 |
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Percentage of Participants With a MADRS Response at Week 8
Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01163266)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 28.4 |
Vortioxetine 10 mg | 33.8 |
Vortioxetine 20 mg | 39.2 |
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Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8
The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score-by-week as fixed effects. (NCT01163266)
Timeframe: Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | 2.89 |
Vortioxetine 10 mg | 2.69 |
Vortioxetine 20 mg | 2.59 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects. (NCT01163266)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -5.86 |
Vortioxetine 10 mg | -7.25 |
Vortioxetine 20 mg | -8.26 |
[back to top]
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects. (NCT01163266)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -10.77 |
Vortioxetine 10 mg | -12.96 |
Vortioxetine 20 mg | -14.41 |
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Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20
"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~The HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity." (NCT01163266)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -10.26 |
Vortioxetine 10 mg | -14.55 |
Vortioxetine 20 mg | -17.52 |
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Percentage of Participants With a MADRS Response at Week 8
Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01179516)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 32.9 |
Vortioxetine 10 mg | 37.8 |
Vortioxetine 15 mg | 37.3 |
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Percentage of Participants in MADRS Remission at Week 8
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01179516)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 22.1 |
Vortioxetine 10 mg | 26.6 |
Vortioxetine 15 mg | 23.9 |
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Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8
The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects. (NCT01179516)
Timeframe: Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | 2.65 |
Vortioxetine 10 mg | 2.56 |
Vortioxetine 15 mg | 2.60 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects. (NCT01179516)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -9.38 |
Vortioxetine 10 mg | -10.30 |
Vortioxetine 15 mg | -8.69 |
[back to top]
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects. (NCT01179516)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -12.87 |
Vortioxetine 10 mg | -13.66 |
Vortioxetine 15 mg | -13.36 |
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Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥ 20
"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity." (NCT01179516)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -14.11 |
Vortioxetine 10 mg | -15.07 |
Vortioxetine 15 mg | -12.37 |
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Percentage of Participants With a MADRS Response at Week 8
Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01255787)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 39.3 |
Vortioxetine 5 mg | 49.3 |
Vortioxetine 10 mg | 54.4 |
Vortioxetine 20 mg | 51.0 |
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Percentage of Participants in MADRS Remission at Week 8
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01255787)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 26.7 |
Vortioxetine 5 mg | 24.6 |
Vortioxetine 10 mg | 29.3 |
Vortioxetine 20 mg | 30.9 |
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Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate. (NCT01255787)
Timeframe: Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | 2.54 |
Vortioxetine 5 mg | 2.37 |
Vortioxetine 10 mg | 2.27 |
Vortioxetine 20 mg | 2.36 |
[back to top]
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate. (NCT01255787)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -6.20 |
Vortioxetine 5 mg | -6.38 |
Vortioxetine 10 mg | -7.97 |
Vortioxetine 20 mg | -7.26 |
[back to top]
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate. (NCT01255787)
Timeframe: Baseline and Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -13.99 |
Vortioxetine 5 mg | -14.61 |
Vortioxetine 10 mg | -15.68 |
Vortioxetine 20 mg | -15.82 |
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Maximum Concentration of 5-HT in Cerobrospinal Fluid
The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Intervention | pg/mL (Mean) |
---|
| Day -1 (n=11, 5) | Day 1 (n=11, 5) | Day 14 (n=9, 5) |
---|
Placebo | 67.74 | 24.10 | 51.46 |
,Vortioxetine | 116.60 | 35.46 | 59.80 |
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Maximum Concentration of 5-HIAA in Plasma
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1 (NCT01299805)
Timeframe: Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Intervention | ng/mL (Mean) |
---|
| Day 1 (n=12, 5) | Day 14 (n=10, 5) |
---|
Placebo | 6.97 | 7.10 |
,Vortioxetine | 7.25 | 6.90 |
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Maximum Concentration of 5-HIAA in Cerebrospinal Fluid
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Intervention | ng/mL (Mean) |
---|
| Day -1 (n=12, 5) | Day 1 (n=12, 5) | Day 14 (n=9, 5) |
---|
Placebo | 34.30 | 36.98 | 30.16 |
,Vortioxetine | 29.87 | 31.13 | 20.18 |
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Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Intervention | pg*hr/mL (Mean) |
---|
| Day -1 (n=10, 4) | Day 1 (n=6, 4) | Day 14 (n=9, 5) |
---|
Placebo | 3854399 | 3912292 | 3858350 |
,Vortioxetine | 4183024 | 4224058 | 1718863 |
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Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma
Area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1. (NCT01299805)
Timeframe: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Intervention | ng*hr/mL (Mean) |
---|
| Day 1 (n=12, 5) | Day 14 (n=10, 5) |
---|
Placebo | 145.92 | 140.40 |
,Vortioxetine | 140.01 | 143.69 |
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Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Intervention | pg*hr/mL (Mean) |
---|
| Day -1 (n=11, 5) | Day 1 (n=11, 5) | Day 14 (n=9, 5) |
---|
Placebo | 509.77 | 497.40 | 444.88 |
,Vortioxetine | 987.71 | 627.78 | 1165.73 |
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Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Intervention | ng*hr/mL (Mean) |
---|
| Day -1 (n=12, 5) | Day 1 (n=12, 5) | Day 14 (n=9, 5) |
---|
Placebo | 718.14 | 774.95 | 644.24 |
,Vortioxetine | 620.61 | 636.14 | 429.23 |
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Maximum Concentration of 5-HT in Plasma
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Intervention | pg/mL (Mean) |
---|
| Day -1 (n=10, 4) | Day 1 (n=6, 4) | Day 14 (n=9, 5) |
---|
Placebo | 231500 | 251250 | 242200 |
,Vortioxetine | 273800 | 247667 | 94233.3 |
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Time to Maximum Concentration of 5-HT in Plasma
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Intervention | hours (Mean) |
---|
| Day -1 (n=10, 4) | Day 1 (n=6, 4) | Day 14 (n=9, 5) |
---|
Placebo | 7.26 | 14.42 | 8.40 |
,Vortioxetine | 12.65 | 4.86 | 9.11 |
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Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Intervention | hours (Mean) |
---|
| Day -1 (n=11, 5) | Day 1 (n=11, 5) | Day 14 (n=9, 5) |
---|
Placebo | 7.13 | 6.92 | 4.94 |
,Vortioxetine | 4.30 | 17.32 | 3.02 |
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Time to Maximum Concentration of 5-HIAA in Plasma
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1. (NCT01299805)
Timeframe: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Intervention | hours (Mean) |
---|
| Day 1 (n=12, 5) | Day 14 (n=10, 5) |
---|
Placebo | 15.13 | 18.40 |
,Vortioxetine | 13.02 | 16.80 |
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Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14). (NCT01299805)
Timeframe: Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Intervention | hours (Mean) |
---|
| Day -1 (n=12, 5) | Day 1 (n=12, 5) | Day 14 (n=9, 5) |
---|
Placebo | 19.78 | 19.00 | 9.90 |
,Vortioxetine | 14.16 | 6.24 | 11.70 |
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Number of Patients With Adverse Events (AEs)
(NCT01323478)
Timeframe: Baseline to end of the 4-week safety follow-up period
Intervention | participants (Number) |
---|
| Patients With AEs | Patients With Serious AEs (SAEs) | Patients With AEs Leading to Withdrawal |
---|
Vortioxetine 15 or 20 mg/Day | 56 | 1 | 7 |
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Risk of Suicidality Using C-SSRS Scores
The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period. (NCT01323478)
Timeframe: Up to 52 weeks
Intervention | participants (Number) |
---|
| No suicidal ideation or behaviour | Any non-suicidal self-injurious behavior | Suicidal Ideation | Preparatory action towards imminent suicidal behav | Not fatal suicide attempt | Completed suicide |
---|
Vortioxetine 15 or 20 mg/Day | 67 | 0 | 4 | 0 | 0 | 0 |
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Change From Baseline in CGI-S Score After 52 Weeks of Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT01323478)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 15 or 20 mg/Day | -1.49 |
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Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. (NCT01323478)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 15 or 20 mg/Day | -7.85 |
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Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT01323478)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 15 or 20 mg/Day | -10.9 |
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Percentage of Patients Who Withdrew Due to Intolerance to Treatment
(NCT01323478)
Timeframe: Baseline to Week 52
Intervention | percentage of patients (Number) |
---|
Vortioxetine 15 or 20 mg/Day | 9.9 |
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Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
(NCT01323478)
Timeframe: Baseline and Week 52
Intervention | percentage of patients (Number) |
---|
Vortioxetine 15 or 20 mg/Day | 80.9 |
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ASEX Total Score After 52 Weeks of Treatment
"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction." (NCT01323478)
Timeframe: Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 15 or 20 mg/Day | 18.60 |
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Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
(NCT01323478)
Timeframe: Baseline from lead-in study 13267A (NCT01140906) and Week 52
Intervention | percentage of patients (Number) |
---|
Vortioxetine 15 or 20 mg/Day | 93.6 |
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SDS Total Score After 52 Weeks of Treatment
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. (NCT01323478)
Timeframe: Week 52
Intervention | units on a scale (Mean) |
---|
Vortioxetine 15 or 20 mg/Day | 4.85 |
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Percentage of Patients With MADRS Response After 8 Weeks of Treatment
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline. (NCT01355081)
Timeframe: Baseline, Week 8
Intervention | percentage of participants (Number) |
---|
Vortioxetine 5 mg | 51.3 |
Vortioxetine 10 mg | 45.9 |
Placebo | 39.8 |
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Percentage of Patients With MADRS Remission After 8 Weeks of Treatment
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10. (NCT01355081)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Vortioxetine 5 mg | 29.4 |
Vortioxetine 10 mg | 28.7 |
Placebo | 22.0 |
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Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment
"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate." (NCT01355081)
Timeframe: Baseline, Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Vortioxetine 5 mg | 2.44 |
Vortioxetine 10 mg | 2.57 |
Placebo | 2.66 |
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Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment
The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate. (NCT01355081)
Timeframe: Baseline, Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Vortioxetine 5 mg | -9.56 |
Vortioxetine 10 mg | -8.54 |
Placebo | -8.40 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment
The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate. (NCT01355081)
Timeframe: Baseline, Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Vortioxetine 5 mg | -5.01 |
Vortioxetine 10 mg | -4.02 |
Placebo | -2.91 |
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Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment
MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate. (NCT01355081)
Timeframe: Baseline, Week 8
Intervention | scores on a scale (Least Squares Mean) |
---|
Vortioxetine 5 mg | -15.84 |
Vortioxetine 10 mg | -14.85 |
Placebo | -13.81 |
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Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed
The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. Normal sexual functioning is defined as a CSFQ-14 total score of >41 for women and >47 for men. Abnormal sexual functioning is defined as a CSFQ-14 total score of ≤41 for women and ≤47 for men. All subjects entered the study with abnormal sexual functioning. A shift to normal indicates that symptoms have improved. (NCT01364649)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8
Intervention | number of participants (Number) |
---|
| Week 1 (n=213, 205) | Week 2 (n=217, 206) | Week 4 (n=217, 206) | Week 6 (n=217, 206) | Week 8 (n=217, 206) |
---|
Escitalopram | 36 | 63 | 84 | 93 | 91 |
,Vortioxetine | 48 | 81 | 93 | 112 | 113 |
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Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed
The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix. (NCT01364649)
Timeframe: Baseline and Weeks 1, 2, 4 and 6
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 1 (n=213, 206) | Week 2 (n=203, 200) | Week 4 (n=187, 188) | Week 6 (n=175, 176) |
---|
Escitalopram | 2.2 | 3.7 | 4.8 | 6.4 |
,Vortioxetine | 2.5 | 4.9 | 7.0 | 8.0 |
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Risk of Suicidality Using C-SSRS Scores
"The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient.~For 2 patients in each treament group (6 in total) the CSSRS assessments are missing during study." (NCT01422213)
Timeframe: Up to 8 weeks
Intervention | participants (Number) |
---|
| No suicidal ideation or behaviour | Any non-suicidal self-injurious behavior | Any suicidal ideation or behaviour |
---|
Placebo | 173 | 0 | 21 |
,Vortioxetine 10 mg | 175 | 0 | 18 |
,Vortioxetine 20 mg | 178 | 0 | 27 |
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Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline
(NCT01422213)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 29.4 |
Vortioxetine 10 mg | 47.7 |
Vortioxetine 20 mg | 58.8 |
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Proportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10)
(NCT01422213)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Placebo | 17.0 |
Vortioxetine 10 mg | 29.5 |
Vortioxetine 20 mg | 38.2 |
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Clinical Status Using CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. (NCT01422213)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | 2.85 |
Vortioxetine 10 mg | 2.24 |
Vortioxetine 20 mg | 1.99 |
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Change From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-score
"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.~The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables.~In the week 1 analysis the vortioxetine 10 and 20 mg groups were pooled because patients randomized to vortioxetine 20 mg received vortioxetine 10 mg in the first week of the study." (NCT01422213)
Timeframe: Baseline and Week 1
Intervention | z score (Least Squares Mean) |
---|
Placebo | -0.079 |
Vortioxetine 10 mg | 0.042 |
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Change From Baseline to Week 8 in CGI-S Score
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -1.15 |
Vortioxetine 10 mg | -1.80 |
Vortioxetine 20 mg | -2.00 |
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Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)
Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility. (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | seconds (Mean) |
---|
Placebo | -5.97 |
Vortioxetine 10 mg | -9.97 |
Vortioxetine 20 mg | -10.43 |
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Change From Baseline to Week 8 in DSST (Number of Correct Symbols)
"Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning). as a description of DSST." (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | number of correct symbols (Mean) |
---|
Placebo | 4.83 |
Vortioxetine 10 mg | 9.03 |
Vortioxetine 20 mg | 9.09 |
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Change From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-score
"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.~The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables." (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | z score (Least Squares Mean) |
---|
Placebo | -0.189 |
Vortioxetine 10 mg | 0.041 |
Vortioxetine 20 mg | -0.036 |
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Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores
"DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).~RAVLT assesses verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.~The scores are standardized by subtracting the overall mean change from baseline from the individual change from baseline and dividing by the standard deviation estimate of the change from baseline. The 2 tests, DSST and RAVLT are each assigned a weight of 0.5, the 2 subtests of RAVLT are each assigned a weight of 0.25." (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | z score (Mean) |
---|
Placebo | -0.235 |
Vortioxetine 10 mg | 0.128 |
Vortioxetine 20 mg | 0.095 |
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Change From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function)
(NCT01422213)
Timeframe: Baseline and Week 8
Intervention | seconds (Mean) |
---|
Placebo | -10.94 |
Vortioxetine 10 mg | -17.69 |
Vortioxetine 20 mg | -17.45 |
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Change From Baseline to Week 8 in MADRS Total Score
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Placebo | -10.85 |
Vortioxetine 10 mg | -15.56 |
Vortioxetine 20 mg | -17.55 |
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Change From Baseline to Week 8 in RAVLT (Acquisition)
Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded. (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | number of words correctly recalled (Mean) |
---|
Placebo | 3.06 |
Vortioxetine 10 mg | 4.08 |
Vortioxetine 20 mg | 3.65 |
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Change From Baseline to Week 8 in RAVLT (Delayed Recall)
Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded. (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | number of words correctly recalled (Mean) |
---|
Placebo | 0.91 |
Vortioxetine 10 mg | 1.63 |
Vortioxetine 20 mg | 1.56 |
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Change From Baseline to Week 8 in the CRT (Attention)
(NCT01422213)
Timeframe: Baseline and Week 8
Intervention | log10 (ms) (Mean) |
---|
Placebo | -0.015 |
Vortioxetine 10 mg | -0.046 |
Vortioxetine 20 mg | -0.023 |
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Change From Baseline to Week 8 in the SRT (Speed of Processing)
"Simple Reaction Time (SRT) is designed to assess psychomotor speed, and Choice Reaction Time (CRT) is designed to assess visual attention. Two computerised tests, part of the CogState battery were used to measure SRT and CRT in milliseconds:~The detection task measures SRT: the patient presses a yes button, whenever an onscreen playing card is turned over.~The identification task measures CRT: the patient presses a yes button whenever an onscreen playing card is turned over and is red, or a no button if the card is not red." (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | log10 (ms) (Mean) |
---|
Placebo | -0.007 |
Vortioxetine 10 mg | -0.053 |
Vortioxetine 20 mg | -0.037 |
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Change From Baseline to Week 8 in the TMT A (Speed of Processing)
Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part A assesses cognitive processing speed. The lower the score the faster the processing speed. (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | seconds (Mean) |
---|
Placebo | -7.07 |
Vortioxetine 10 mg | -10.84 |
Vortioxetine 20 mg | -10.87 |
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Change From Baseline to Week 8 in the TMT B (Executive Function)
TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set. (NCT01422213)
Timeframe: Baseline and Week 8
Intervention | seconds (Mean) |
---|
Placebo | -13.84 |
Vortioxetine 10 mg | -21.41 |
Vortioxetine 20 mg | -22.85 |
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Change From Baseline in MADRS Total Score at Week 8
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT01488071)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | -16.53 |
Agomelatine 25 mg or 50 mg | -14.38 |
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Change From Baseline in MADRS Total Score at Week 12
(NCT01488071)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | -18.95 |
Agomelatine 25 mg or 50 mg | -16.92 |
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Change From Baseline in HAM-A Total Score at Week 8
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56; higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT01488071)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | -11.68 |
Agomelatine 25 mg or 50 mg | -9.79 |
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Change From Baseline in HAM-A Total Score at Week 12
(NCT01488071)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | -13.52 |
Agomelatine 25 mg or 50 mg | -11.59 |
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Change From Baseline in CGI-S Score at Week 8
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT01488071)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | -1.84 |
Agomelatine 25 mg or 50 mg | -1.55 |
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Change From Baseline in CGI-S Score at Week 12
(NCT01488071)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | -2.20 |
Agomelatine 25 mg or 50 mg | -1.93 |
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Change From Baseline in SDS Total Score at Week 8
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT01488071)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | -9.28 |
Agomelatine 25 mg or 50 mg | -7.06 |
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Change in Clinical Status Using CGI-I Score at Week 12
(NCT01488071)
Timeframe: Week 12
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | 1.74 |
Agomelatine 25 mg or 50 mg | 1.99 |
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Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)
(NCT01488071)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Vortioxetine 10 mg or 20 mg | 55.2 |
Agomelatine 25 mg or 50 mg | 39.4 |
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Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)
(NCT01488071)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Vortioxetine 10 mg or 20 mg | 40.5 |
Agomelatine 25 mg or 50 mg | 29.5 |
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Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
(NCT01488071)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Vortioxetine 10 mg or 20 mg | 69.8 |
Agomelatine 25 mg or 50 mg | 56.0 |
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Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
(NCT01488071)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Vortioxetine 10 mg or 20 mg | 61.5 |
Agomelatine 25 mg or 50 mg | 47.3 |
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Change in Clinical Status Using CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. Higher score = more affected. (NCT01488071)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | 1.97 |
Agomelatine 25 mg or 50 mg | 2.22 |
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Change From Baseline in SDS Total Score at Week 12
(NCT01488071)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Vortioxetine 10 mg or 20 mg | -10.99 |
Agomelatine 25 mg or 50 mg | -9.24 |
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t½ of Vortioxetine
Half-life of vortioxetine in plasma (NCT01491035)
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Intervention | h (Median) |
---|
Adolescents, 5 mg | 46 |
Adolescents, 10 mg | 56 |
Adolescents, 15 mg | 50 |
Adolescents, 20 mg | 40 |
Children, 5 mg | 45 |
Children, 10 mg | 52 |
Children, 15 mg | 71 |
Children, 20 mg | 62 |
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Cmax of Vortioxetine
Maximum plasma concentration of vortioxetine (NCT01491035)
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level
Intervention | ng/mL (Median) |
---|
Adolescents, 5 mg | 4.3 |
Adolescents, 10 mg | 7.8 |
Adolescents, 15 mg | 15 |
Adolescents, 20 mg | 16 |
Children, 5 mg | 5.0 |
Children, 10 mg | 14 |
Children, 15 mg | 26 |
Children, 20 mg | 31 |
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Oral Clearance (CL/F) of Vortioxetine
Oral clearance expressed as a function of bioavailability (NCT01491035)
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Intervention | L/h (Median) |
---|
Adolescents, 5 mg | 60 |
Adolescents, 10 mg | 50 |
Adolescents, 15 mg | 50 |
Adolescents, 20 mg | 61 |
Children, 5 mg | 50 |
Children, 10 mg | 42 |
Children, 15 mg | 29 |
Children, 20 mg | 34 |
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t½ of Lu AA34443
Half-life of the major, inactive metabolite Lu AA34443 in plasma (NCT01491035)
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Intervention | h (Median) |
---|
Adolescents, 5 mg | 26 |
Adolescents, 10 mg | 33 |
Adolescents, 15 mg | 24 |
Adolescents, 20 mg | 24 |
Children, 5 mg | 20 |
Children, 10 mg | 19 |
Children, 15 mg | 29 |
Children, 20 mg | 27 |
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Cmax of Lu AA34443
Maximum plasma concentration of the major, inactive metabolite Lu AA34443 (NCT01491035)
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level
Intervention | ng/mL (Median) |
---|
Adolescents, 5 mg | 3.5 |
Adolescents, 10 mg | 14 |
Adolescents, 15 mg | 16 |
Adolescents, 20 mg | 38 |
Children, 5 mg | 7.8 |
Children, 10 mg | 15 |
Children, 15 mg | 20 |
Children, 20 mg | 47 |
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AUC(0-24h) of Lu AA34443
Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443 (NCT01491035)
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Intervention | ng*h/mL (Median) |
---|
Adolescents, 5 mg | 56 |
Adolescents, 10 mg | 223 |
Adolescents, 15 mg | 266 |
Adolescents, 20 mg | 544 |
Children, 5 mg | 115 |
Children, 10 mg | 241 |
Children, 15 mg | 429 |
Children, 20 mg | 646 |
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AUC(0-24h) of Vortioxetine
Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours (NCT01491035)
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Intervention | ng*h/mL (Median) |
---|
Adolescents, 5 mg | 82 |
Adolescents, 10 mg | 144 |
Adolescents, 15 mg | 283 |
Adolescents, 20 mg | 304 |
Children, 5 mg | 89 |
Children, 10 mg | 261 |
Children, 15 mg | 492 |
Children, 20 mg | 562 |
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Change From Baseline to Week 8 in the Trail Making Test B (TMT-B)
The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower score for TMT-B represents better executive function. A decrease in score over the study represents an improvement in executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | seconds (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | -18.73 |
Duloxetine | -14.60 |
Placebo | -9.06 |
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Change in Time From Baseline to Week 8 in the Stroop Test
The STROOP test assesses the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises of 2 sheets with 50 words each, up to 50 correct responses for each of the congruent and incongruent Stroop tests. Participants have 4 minutes to name the ink color of each word. Lower time to complete the test indicates better performance. Higher number of correct responses indicates better responses. A decrease in the time to complete the tests and an increase in the number of correct responses both indicate improvement over the course of the study. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | seconds (Mean) |
---|
| Congruent (n=174,187,167) | Incongruent (n=172,186,166) |
---|
Duloxetine | -4.54 | -9.83 |
,Placebo | -4.37 | -8.11 |
,Vortioxetine (Lu AA21004) | -3.30 | -8.17 |
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Clinical Global Impressions-Improvement (CGI-I) Score at Week 8
"The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. A MMRM model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis." (NCT01564862)
Timeframe: Baseline, Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | 2.349 |
Duloxetine | 2.235 |
Placebo | 2.639 |
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Change From Baseline to Week 8 in the Detection Task (DT)
"The DT is a computerized test that measures simple reaction time and psychomotor speed. The task requires participants to respond by pressing a yes button as soon as an onscreen playing card is turned over and is red, and by pressing a no button if the card is not red. It takes 2 minutes to be administered. There is no minimum or maximum scores since it is a time-based assessment. Lower score equals better performance. A decrease in score over the course of the study indicates improved speed of processing and psychomotor function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Log10 milliseconds (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | -0.050 |
Duloxetine | -0.039 |
Placebo | -0.033 |
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Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)
The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Correct symbols (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | 4.60 |
Duloxetine | 4.06 |
Placebo | 2.85 |
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Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT)
"The GMLT measures executive functioning and spatial problem solving. Participants learn a hidden pathway through a maze of 10 x 10 grid of tiles on a computer touch screen using step-by-step guess, with trial and error feedback after each step. Once the pathway is learned, participants repeat the same pathway four more times. It usually takes 5-6 minutes to administer this test. Lower score equals better performance. A decrease in score over the course of the study indicates improved executive function.~An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Errors (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | -5.43 |
Duloxetine | -5.16 |
Placebo | -3.49 |
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Change From Baseline to Week 8 in the Identification Task (IT)
"The IT measured choice reaction time: the participant pressed a yes button whenever an onscreen playing card turned face up and was red, or a no button if the card was not red. The IT took on average 2 minutes to complete. Lower scores equal better performance. A decrease in score over the course of the study indicates improved visual attention/vigilance. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate." (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Log10 milliseconds (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | -0.037 |
Duloxetine | -0.030 |
Placebo | -0.024 |
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Change From Baseline to Week 8 in the One-Back Task
The One-Back test measures the cognitive domain of attention and working memory through yes or no responses to 30 trials. The task requires participants to report when a stimulus item presented serially is the same as an item one step back from the item at hand for a total correct responses 0 to 100. It usually takes 2-3 minutes to be administered. Higher scores equal better performance. An increase in score over the course of the study indicates improved attention/working memory. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | Log 10 milliseconds (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | -0.028 |
Duloxetine | -0.024 |
Placebo | -0.022 |
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Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore
PDQ is a patient-rated scale designed to subjectively assess cognitive dysfunction, comprising four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization for a total possible score of 0 to 40. The subscale Attention/Concentration is the sum of items 1, 5, 9, 13, and 17 with a range of 0-20; while the subscale Planning/Organization is the sum of items 4, 8, 12, 16, and 20 with the score range of 0 to 20. The scores of the subscales Attention/Concentration and Planning/Organization were summed. Higher scores reflect greater participant-perceived cognitive dysfunction in the domains identified. A decrease in score represents an improvement in subjective cognitive function in the domains identified. A Mixed Model Repeated Measures (MMRM) model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | -8.9 |
Duloxetine | -9.3 |
Placebo | -6.3 |
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Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score
"The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). A MMRM model with baseline*week, center, week, treatment and week*treatment as factors was used for analyses." (NCT01564862)
Timeframe: Baseline, Week 1, Week 4 and Week 8
Intervention | score on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 1 (n=174, 187,167) | Change from Baseline at Week 4 (n=173,184,165) | Change from Baseline at Week 8 (n=169,179,161) |
---|
Duloxetine | -0.353 | -1.170 | -1.698 |
,Placebo | -0.243 | -0.617 | -1.225 |
,Vortioxetine (Lu AA21004) | -0.289 | -0.951 | -1.546 |
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Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression
Improvement of Cognitive Dysfunction is determined using the change from Baseline to Week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score and the Digital Symbol Substitution Test (DSST) total number of correct symbols. The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression). The DSST assesses relative contributions of speed, memory, executive function and visual scanning. The proportion of direct effect from treatment = DSST difference / (DSST difference + coefficient*MADRS difference). (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | proportion of direct effect (Number) |
---|
Vortioxetine (Lu AA21004) | 75.66 |
Duloxetine | 48.69 |
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Percentage of Participants in MADRS Remission at Week 8
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Remission was defined as a MADRS total score ≤10. (NCT01564862)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
Vortioxetine (Lu AA21004) | 30.3 |
Duloxetine | 33.7 |
Placebo | 21.6 |
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Percentage of Participants With MADRS Response at Week 8
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Response was defined as a ≥50% decrease in MADRS Total Score from Baseline. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | percentage of participants (Number) |
---|
Vortioxetine (Lu AA21004) | 50.9 |
Duloxetine | 54.5 |
Placebo | 41.3 |
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Change From Baseline to Week 8 in the MADRS Total Score
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. (NCT01564862)
Timeframe: Baseline, Week 1, Week 4 and Week 8
Intervention | score on a scale (Mean) |
---|
| Change at Week 1 | Change at Week 4 | Change at Week 8 |
---|
Duloxetine | -4.6 | -11.6 | -15.5 |
,Placebo | -3.4 | -8.0 | -12.3 |
,Vortioxetine (Lu AA21004) | -3.7 | -9.8 | -14.3 |
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Change From Baseline to Week 8 in the Trail Making Test (TMT-A)
The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower scores represent better speed of processing. A decrease in score over the study represents an improvement in speed in processing. An ANCOVA model was used with treatment and center as fixed factors and the baseline value as a covariate. (NCT01564862)
Timeframe: Baseline and Week 8
Intervention | seconds (Least Squares Mean) |
---|
Vortioxetine (Lu AA21004) | -7.70 |
Duloxetine | -8.06 |
Placebo | -6.65 |
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Change From Baseline in MADRS Total Score at Week 8
Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT01571453)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine | -19.36 |
Venlafaxine | -18.16 |
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Change in CGI-S Score From Baseline to Week 8
Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT01571453)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine | -2.26 |
Venlafaxine | -2.12 |
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Change in HAM-A Total Score From Baseline to Week 8
Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT01571453)
Timeframe: Baseline and Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine | -11.38 |
Venlafaxine | -10.56 |
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MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)
(NCT01571453)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|
Vortioxetine | 66.5 |
Venlafaxine | 61.4 |
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Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)
(NCT01571453)
Timeframe: Week 8
Intervention | percentage of patients (Number) |
---|
Vortioxetine | 43.1 |
Venlafaxine | 41.4 |
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CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected. (NCT01571453)
Timeframe: Week 8
Intervention | units on a scale (Mean) |
---|
Vortioxetine | 1.99 |
Venlafaxine | 2.14 |
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AUC(0-inf)u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine
AUC(0-inf)u is a measure of total unbound plasma exposure to the drug from time zero extrapolated to infinity. (NCT02170220)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Intervention | ng*hr/mL (Mean) |
---|
Vortioxetine 5 mg: Normal Hepatic Function Cohort | 1.806 |
Vortioxetine 5 mg: Severe Hepatic Impairment Cohort | 2.558 |
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AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]). (NCT02170220)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Intervention | ng*hr/mL (Mean) |
---|
Vortioxetine 5 mg: Normal Hepatic Function Cohort | 166.955 |
Vortioxetine 5 mg: Severe Hepatic Impairment Cohort | 188.663 |
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AUC(0-tlqc)u: Area Under the Unbound Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine
AUC(0-tlqc)u is a measure of total unbound plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]u). (NCT02170220)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Intervention | ng*hr/mL (Mean) |
---|
Vortioxetine 5 mg: Normal Hepatic Function Cohort | 1.611 |
Vortioxetine 5 mg: Severe Hepatic Impairment Cohort | 1.653 |
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Cmax: Maximum Observed Plasma Concentration for Vortioxetine
Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT02170220)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Intervention | ng/mL (Mean) |
---|
Vortioxetine 5 mg: Normal Hepatic Function Cohort | 2.078 |
Vortioxetine 5 mg: Severe Hepatic Impairment Cohort | 1.670 |
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Cmaxu: Maximum Observed Unbound Plasma Concentration for Vortioxetine
Maximum Observed Unbound Plasma Concentration (Cmaxu) is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve. (NCT02170220)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Intervention | ng/mL (Mean) |
---|
Vortioxetine 5 mg: Normal Hepatic Function Cohort | 0.020 |
Vortioxetine 5 mg: Severe Hepatic Impairment Cohort | 0.014 |
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AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. (NCT02170220)
Timeframe: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Intervention | ng*hr/mL (Mean) |
---|
Vortioxetine 5 mg: Normal Hepatic Function Cohort | 187.202 |
Vortioxetine 5 mg: Severe Hepatic Impairment Cohort | 288.053 |
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Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)
"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.~Severity of VMS:~The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe" (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Mean) |
---|
Open-label Vortioxetine | -0.27 |
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Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)
Anxiety was measured by self-report responses to Beck Anxiety Inventory (BAI). It is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults. Higher scores on the BAI indicate more anxiety symptoms. The range of BAI scores is from 0 to 63, with 0-9=Minimal anxiety, 10-16=Mild anxiety, 17-29=Moderate anxiety, and 30-63=Severe anxiety. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | -7 |
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Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)
Fatigue symptoms were assessed by the Clinical Global Impression-Fatigue (CGI-F) scale.The CGI-F is a single item global assessment scales to specifically evaluate symptoms of fatigue. Higher scores indicate more fatigue symptoms. The range of scores is from 0-7. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | -1 |
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Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)
Severity of illness was assessed by the Clinical Global Impression-Severity (CGI-S) Scale. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. The range of scores is 0-7. Higher scores indicate greater severity of illness. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | -1 |
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Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)
Cognition and physical functioning was measured by self-report responses to Cognitive and Physical Functioning Questionnaire (CPFQ).The range of scores is from 7-42. Higher scores indicate lower cognitive and executive functioning. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | -13 |
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Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)
"Processing speed, working memory, visuospatial processing and attention was assessed by the Digit Symbol Substitution Test (DSST).~The DSST test requires the examinee to transcribe a unique geometric symbol with its corresponding Arabic number. The examinee is initially shown a key containing the numbers from 1 to 9. Under each number there is a corresponding geometric symbol. The examinee is then shown a series of boxes containing numbers in the top boxes, and blank boxes below them. After a short practice trial, they are then asked to copy the corresponding geometric symbol under each number. The raw score is the number of correct items completed within the prescribed time limit. Higher scores indicate faster processing speed, working memory, and visuospatial processing and attention. The range of scores is 0-63." (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | 8.5 |
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Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)
"Menopause related symptoms were assessed using the Greene Climacteric Scale (GCS). The Greene Scale provides a brief measure of menopause symptoms. It can be used to assess changes in different symptoms, before and after menopause treatment. Three main areas are measured:~1. Psychological (items 1-11). 2. Physical (items 12-18). 3. Vasomotor (items 19, 20).~A higher score indicates that menopause symptoms are more bothersome. The range of scores is from 0 to 63." (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | -18.5 |
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Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)
"Quality of life, menopause-specific, is assessed by the Menopause Specific Quality of Life (MENQOL).~The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a 1 and endorsement a 2, plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8. Higher scores indicate that menopause symptoms are more bothersome." (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | -1.74 |
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Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)
The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Mean) |
---|
Open-label Vortioxetine | -22.8 |
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Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)
Pain symptoms were assessed by the Pain Assessment (PEG). The PEG is a three-item scale assessing pain intensity and interference. A higher score indicates more pain symptoms. The range of scores is from 0 to 30. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | -4 |
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Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)
Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. The range of scores is 0-21. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Median) |
---|
Open-label Vortioxetine | -5 |
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Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)
Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | hot flashes per day (Mean) |
---|
Open-label Vortioxetine | -1.33 |
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Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)
Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | hot flashes per night (Mean) |
---|
Open-label Vortioxetine | -1.15 |
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Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)
"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.~Severity of VMS:~The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe" (NCT02234362)
Timeframe: Baseline and Week 8 (Visit 5)
Intervention | units on a scale (Mean) |
---|
Open-label Vortioxetine | -0.28 |
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Change in BRIEF-A Subscales - Emotional Control
The BRIEF-A subscale Emotional Control is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -3.4 |
Vortioxetine 10mg, Combined | -4.8 |
Vortioxetine 20mg, Combined | -3.5 |
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Change in AISRS Inattention Sub-score
The AISRS inattentive subscale score consists of 9 items from the AISRS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Stage 1 | -6.5 |
Vortioxetine 10mg, Stage 1 | -6.0 |
Vortioxetine 20mg, Stage 1 | -5.9 |
Placebo, Stage 2 | -1.9 |
Vortioxetine 10mg, Stage 2 | -2.0 |
Vortioxetine 20mg, Stage 2 | -1.6 |
Placebo, Combined | -4.2 |
Vortioxetine 10mg, Combined | -4.0 |
Vortioxetine 20mg, Combined | -3.8 |
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Change in Adult ADHD Self-Report Scale (ASRS) Total Score
"The Adult ADHD Self-Report Scale (ASRS) is a patient-rated scale designed to assess the ADHD symptoms in adults based on the diagnostic criteria of DSM-IVTM. The ASRS consist of 18 items, each rated on a 5-point scale from Never to Very Often. The categories Never and Rarely were combined when calculating the total score to mirror the scoring of the AISRS, with 0 representing Never/Rarely and 3 representing Very Often. The Total Score ranges from 0 to 54. A reduction in score indicates less severity of ADHD." (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -4.9 |
Vortioxetine 10mg, Combined | -6.5 |
Vortioxetine 20mg, Combined | -3.4 |
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Change in Adult ADHD Quality of Life Measure (AAQoL) Total Score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Total score is based on all 29 items and ranges from 29 to 145. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | 7.7 |
Vortioxetine 10mg, Combined | 9.1 |
Vortioxetine 20mg, Combined | 5.4 |
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Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Stage 1 | -12.4 |
Vortioxetine 10mg, Stage 1 | -12.8 |
Vortioxetine 20mg, Stage 1 | -11.6 |
Placebo, Stage 2 | -4.1 |
Vortioxetine 10mg, Stage 2 | -3.9 |
Vortioxetine 20mg, Stage 2 | -2.9 |
Placebo, Combined | -8.3 |
Vortioxetine 10mg, Combined | -8.3 |
Vortioxetine 20mg, Combined | -7.3 |
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Change in AAQoL Subscales - Relationships Sub-score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Relationship subscale is based on 5 items and ranges from 5 to 25. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | 7.4 |
Vortioxetine 10mg, Combined | 8.1 |
Vortioxetine 20mg, Combined | 6.0 |
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Change in AAQoL Subscales - Psychological Health Sub-score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Psychological Health subscale is based on 6 items and ranges from 6 to 30. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | 6.7 |
Vortioxetine 10mg, Combined | 10.3 |
Vortioxetine 20mg, Combined | 5.7 |
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Change in AAQoL Subscales - Life Productivity Sub-score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life productivity subscale is based on 11 items and ranges from 11 to 55. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | 10.9 |
Vortioxetine 10mg, Combined | 11.6 |
Vortioxetine 20mg, Combined | 6.4 |
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Change in AAQoL Subscales - Life Outlook Sub-score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life Outlook subscale is based on 7 items and ranges from 7 to 35. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | 3.7 |
Vortioxetine 10mg, Combined | 5.0 |
Vortioxetine 20mg, Combined | 3.0 |
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Change BRIEF-A Subscales - Initiate
The BRIEF-A subscale Initiate is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -6.2 |
Vortioxetine 10mg, Combined | -5.8 |
Vortioxetine 20mg, Combined | -4.2 |
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Change in Perceived Deficits Questionnaire - Depression (PDQ-D) Total Score
The PDQ-D is a patient-rated scale designed to assess cognitive impairment/dysfunction adapted for MDD. Each item is rated on a scale from 0 (never) to 4 (almost always). The total score of the 20 items ranges from 0 to 80 with higher scores reflect greater subjective cognitive impairment. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -7.6 |
Vortioxetine 10mg, Combined | -9.3 |
Vortioxetine 20mg, Combined | -6.3 |
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Change AISRS Hyperactivity/Impulsivity Sub-score
The AISRS hyperactive/impulsive subscale score consists of 9 items from the AISRS which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Stage 1 | -5.9 |
Vortioxetine 10mg, Stage 1 | -7.0 |
Vortioxetine 20mg, Stage 1 | -5.7 |
Placebo, Stage 2 | -2.1 |
Vortioxetine 10mg, Stage 2 | -2.0 |
Vortioxetine 20mg, Stage 2 | -1.2 |
Placebo, Combined | -4.0 |
Vortioxetine 10mg, Combined | -4.5 |
Vortioxetine 20mg, Combined | -3.4 |
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Response (Defined as a CGI-I Score of 1 or 2), Stage 1
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening. (NCT02327013)
Timeframe: Week 6
Intervention | percentages of participants (Number) |
---|
Placebo, Combined | 43 |
Vortioxetine 10mg, Combined | 13 |
Vortioxetine 20mg, Combined | 11 |
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Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score
"The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from All of the Time (score 5) to None of the Time (score 0), or Does Not Apply to My Job. The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24,9%." (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | percentage of days lost (Least Squares Mean) |
---|
Placebo, Stage 1 | -2.4 |
Vortioxetine 10mg, Stage 1 | -2.5 |
Vortioxetine 20mg, Stage 1 | -2.4 |
Placebo, Stage 2 | -0.8 |
Vortioxetine 10mg, Stage 2 | -0.9 |
Vortioxetine 20mg, Stage 2 | -0.7 |
Placebo, Combined | -1.6 |
Vortioxetine 10mg, Combined | -1.7 |
Vortioxetine 20mg, Combined | -1.5 |
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Percentage of Patients Responding (Response Defined as 30% or Greater Reduction From Baseline in AISRS Total Score)
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | percentage of participants (Number) |
---|
Placebo, Combined | 30.9 |
Vortioxetine 10mg, Combined | 27.5 |
Vortioxetine 20mg, Combined | 23.1 |
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Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score
The SDS comprises a series of patient rated scales designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and 3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment. The number of days lost and the number of underproductive days last from work/school due to symptoms are also captured. The total score is calculated as a sum of the 3 visual analogue scales, ranges from 0 to 30. A higher score represents more severe functional impairment. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Stage 1 | -5.3 |
Vortioxetine 10mg, Stage 1 | -7.9 |
Vortioxetine 20mg, Stage 1 | -7.4 |
Placebo, Stage 2 | 0.6 |
Vortioxetine 10mg, Stage 2 | -0.9 |
Vortioxetine 20mg, Stage 2 | -1.4 |
Placebo, Combined | -2.4 |
Vortioxetine 10mg, Combined | -4.4 |
Vortioxetine 20mg, Combined | -4.4 |
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Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score
BRIEF-A is a validated questionnaire composed of 75-item within nine non-overlapping scales: 4 scales in the Behavioral Regulation Index (BRI) (inhibit, shift, emotional control, and self-monitor), and 5 scales in the Metacognition Index (MI) (initiate, working memory, plan/organise, task monitor, and organization of materials). Each item is rated on a 3-point scale with the numeric score of 1 to 3. The BRIEF-A yields an overall score (Global Executive Composite) composed of two index scores, the MI and the BRI. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Stage 1 | -9.9 |
Vortioxetine 10mg, Stage 1 | -12.5 |
Vortioxetine 20mg, Stage 1 | -11.4 |
Placebo, Stage 2 | -3.0 |
Vortioxetine 10mg, Stage 2 | -3.5 |
Vortioxetine 20mg, Stage 2 | 2.1 |
Placebo, Combined | -6.5 |
Vortioxetine 10mg, Combined | -8.0 |
Vortioxetine 20mg, Combined | -4.6 |
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Clinical Global Impression - Global Improvement (CGI-I) Score
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening. (NCT02327013)
Timeframe: Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Stage 1 | 3.01 |
Vortioxetine 10mg, Stage 1 | 2.93 |
Vortioxetine 20mg, Stage 1 | 3.15 |
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Change in WLQ Using the Global Productivity Index
"The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from All of the Time (score 5) to None of the Time (score 0), or Does Not Apply to My Job. The Global Productivity Index is calculated as a weighed sum of the 4 dimensions, and ranges from 0.000 to 0.286. Reduction in score indicates less work limitation." (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | Index (Least Squares Mean) |
---|
Placebo, Combined | -0.0 |
Vortioxetine 10mg, Combined | -0.0 |
Vortioxetine 20mg, Combined | -0.0 |
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Change in WLQ Domain Scores - Physical Demands
Physical Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -5.5 |
Vortioxetine 10mg, Combined | -5.0 |
Vortioxetine 20mg, Combined | -4.6 |
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Change in WLQ Domain Scores - Output Demands
Output Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -8.9 |
Vortioxetine 10mg, Combined | -7.1 |
Vortioxetine 20mg, Combined | -7.2 |
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Change in WLQ Domain Scores - Mental-Interpersonal Work Demands
Mental-Interpersonal Work Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -8.4 |
Vortioxetine 10mg, Combined | -8.2 |
Vortioxetine 20mg, Combined | -6.2 |
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Change in WLQ Domain Scores - Limitations Handling Time
Limitations Handling Time is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -5.6 |
Vortioxetine 10mg, Combined | -7.7 |
Vortioxetine 20mg, Combined | -2.2 |
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Change in SDS Item Scores - Work
The SDS item work is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -1.2 |
Vortioxetine 10mg, Combined | -2.0 |
Vortioxetine 20mg, Combined | -2.1 |
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Change in SDS Item Scores - Social Life
The SDS item social life is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -1.1 |
Vortioxetine 10mg, Combined | -1.7 |
Vortioxetine 20mg, Combined | -1.5 |
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Change in SDS Item Scores - Number of Underproductive Days
This SDS item captures the number of underproductive days (see outcome 4) (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | days (Least Squares Mean) |
---|
Placebo, Combined | -1.2 |
Vortioxetine 10mg, Combined | -1.0 |
Vortioxetine 20mg, Combined | -1.2 |
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Change in SDS Item Scores - Number of Days Lost
This SDS item captures days lost from school or work (see outcome 4). (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | days (Least Squares Mean) |
---|
Placebo, Combined | -0.3 |
Vortioxetine 10mg, Combined | -0.2 |
Vortioxetine 20mg, Combined | -0.1 |
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Change in SDS Item Scores - Family
The SDS item family is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -1.5 |
Vortioxetine 10mg, Combined | -1.8 |
Vortioxetine 20mg, Combined | -1.5 |
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Change in PDQ-D Subscales - Attention and Concentration Sub-score
The PDQ-D attention/concentration sub-score consists of items 1, 5, 9, 13, and 17 of the PDQ with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -1.7 |
Vortioxetine 10mg, Combined | -2.3 |
Vortioxetine 20mg, Combined | -1.8 |
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Change in PDQ-D Sub-scales - Retrospective Memory Sub-score
The PDQ-D retrospective memory sub-score consists of items 2, 6, 10, 14, and 18 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -1.8 |
Vortioxetine 10mg, Combined | -2.4 |
Vortioxetine 20mg, Combined | -1.5 |
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Change in PDQ-D Sub-scales - Prospective Memory Sub-score
The PDQ-D prospective memory sub-score consists of items 3, 7, 11, 15, and 19 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -1.5 |
Vortioxetine 10mg, Combined | -2.3 |
Vortioxetine 20mg, Combined | -0.9 |
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Change in PDQ-D Sub-scales - Planning and Organisation Sub-score
The PDQ-D planning and organisation sub-score consists of items 4, 8, 12, 16, and 20 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -2.4 |
Vortioxetine 10mg, Combined | -2.5 |
Vortioxetine 20mg, Combined | -1.9 |
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Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo, Combined | -0.5 |
Vortioxetine 10mg, Combined | -0.7 |
Vortioxetine 20mg, Combined | -0.6 |
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Change in BRIEF-A Using the Behavioural Regulation Index
The Behavioral Regulation Index (BRI) is an index score of the BRIEF-A and consists of 4 scales: inhibit, shift, emotional control, and self-monitor). Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -5.3 |
Vortioxetine 10mg, Combined | -7.9 |
Vortioxetine 20mg, Combined | -3.9 |
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Change in BRIEF-A Subscales - Working Memory
The BRIEF-A subscale Working Memory is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -7.6 |
Vortioxetine 10mg, Combined | -9.9 |
Vortioxetine 20mg, Combined | -3.8 |
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Change in BRIEF-A Subscales - Task Monitor
The BRIEF-A subscale Task Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -6.4 |
Vortioxetine 10mg, Combined | -7.8 |
Vortioxetine 20mg, Combined | -4.9 |
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Change in BRIEF-A Subscales - Shift
The BRIEF-A subscale Shift is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -5.6 |
Vortioxetine 10mg, Combined | -9.1 |
Vortioxetine 20mg, Combined | -3.5 |
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Change in BRIEF-A Subscales - Self Monitor
The BRIEF-A subscale Self Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -6.5 |
Vortioxetine 10mg, Combined | -11.0 |
Vortioxetine 20mg, Combined | -4.8 |
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Change in BRIEF-A Subscales - Planning/Organize
The BRIEF-A subscale Planning/Organize is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -8.2 |
Vortioxetine 10mg, Combined | -8.7 |
Vortioxetine 20mg, Combined | -6.8 |
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Change in BRIEF-A Subscales - Organization of Materials
The BRIEF-A subscale Organization of Materials is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -4.4 |
Vortioxetine 10mg, Combined | -6.3 |
Vortioxetine 20mg, Combined | -3.2 |
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Change in BRIEF-A Subscales - Inhibit
The BRIEF-A subscale Inhibit is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. (NCT02327013)
Timeframe: Baseline to Week 6
Intervention | T-score (Least Squares Mean) |
---|
Placebo, Combined | -5.5 |
Vortioxetine 10mg, Combined | -8.6 |
Vortioxetine 20mg, Combined | -3.2 |
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Clinical Global Impression Scale-Global Improvement Scale (CGI-I) Score
The CGI-I scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. (NCT02371980)
Timeframe: Week 32
Intervention | scores on scale (Mean) |
---|
Double-blind: Placebo | 4.4 |
Double-blind: Vortioxetine 5 mg | 3.9 |
Double-blind: Vortioxetine 10 mg | 3.5 |
Double-blind: Vortioxetine 20 mg | 3.7 |
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Time From Randomization to Relapse of Major Depressive Disorder During the Entire 32-Week Double-Blind Treatment Period
Relapse was defined as either 1) MADRS Score ≥22, 2) lack of efficacy as determined by the investigator or 3) other unsatisfactory treatment response judged by the investigator. Time to relapse was defined as date of relapse - date of randomization + 1 (where date of relapse is the date of last dose, or date of last contact if date of last dose is missing, for participant with a relapse). Participants without relapse were censored. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score ranges from 0 to 60. Higher scores indicate greater severity of symptoms. The IQR was 25th percentile to 75th percentile. (NCT02371980)
Timeframe: From date of double-blind randomization (Week 16) up to relapse or 32 weeks of Double-blind Period which occurs first (Up to Week 44)
Intervention | weeks (Median) |
---|
Double-blind: Placebo | NA |
Double-blind: Vortioxetine 5 mg | NA |
Double-blind: Vortioxetine 10 mg | NA |
Double-blind: Vortioxetine 20 mg | NA |
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Time From Randomization to Relapse of Major Depressive Disorder During the First 28 Weeks of the 32-Week Double-Blind Treatment Period
Relapse was defined as either 1) MADRS Score ≥22, 2) lack of efficacy as determined by the investigator or 3) other unsatisfactory treatment response judged by the investigator. Time to relapse was defined as date of relapse - date of randomization + 1 (where date of relapse is the date of last dose, or date of last contact if date of last dose is missing, for participant with a relapse). Participants without relapse were censored at date of withdrawal or date of Week 28 visit, whichever was earliest. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score ranges from 0 to 60. Higher scores indicate greater severity of symptoms. The inter-quartile range (IQR) was 25th percentile to 75th percentile. (NCT02371980)
Timeframe: From date of double-blind randomization (Week 16) up to relapse or first 28 weeks of Double-blind Period which occurs first (Up to Week 44)
Intervention | weeks (Median) |
---|
Double-blind: Placebo | NA |
Double-blind: Vortioxetine 5 mg | NA |
Double-blind: Vortioxetine 10 mg | NA |
Double-blind: Vortioxetine 20 mg | NA |
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Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at Each Week Assessed
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participant who have the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness on the following scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill. Baseline II is defined as the last non-missing observation prior to the first dose of double-blind study drug. MMRM was used for analyses. (NCT02371980)
Timeframe: Double-blind Baseline (BL) II and Double-blind Period: Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Intervention | scores on scale (Least Squares Mean) |
---|
| Change From BL II at Week 2 | Change From BL II at Week 4 | Change From BL II at Week 8 | Change From BL II at Week 12 | Change From BL II at Week 16 | Change From BL II at Week 20 | Change From BL II at Week 24 | Change From BL II at Week 28 | Change From BL II at Week 32 |
---|
Double-blind: Placebo | 0.35 | 0.61 | 0.68 | 0.74 | 0.62 | 0.61 | 0.60 | 0.45 | 0.59 |
,Double-blind: Vortioxetine 10 mg | 0.26 | 0.30 | 0.29 | 0.24 | 0.25 | 0.17 | 0.24 | 0.30 | 0.26 |
,Double-blind: Vortioxetine 20 mg | 0.27 | 0.25 | 0.30 | 0.35 | 0.34 | 0.28 | 0.37 | 0.34 | 0.22 |
,Double-blind: Vortioxetine 5 mg | 0.32 | 0.32 | 0.38 | 0.46 | 0.50 | 0.40 | 0.45 | 0.33 | 0.41 |
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Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher score indicates greater severity of symptoms. Baseline II is defined as the last non-missing observation prior to the first dose of double-blind study drug. Mixed model for repeated measures (MMRM) was used for analyses. (NCT02371980)
Timeframe: Double-blind Baseline (BL) II and Double-blind Period: Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Intervention | scores on scale (Least Squares Mean) |
---|
| Change From BL II at Week 2 | Change From BL II at Week 4 | Change From BL II at Week 8 | Change From BL II at Week 12 | Change From BL II at Week 16 | Change From BL II at Week 20 | Change From BL II at Week 24 | Change From BL II at Week 28 | Change From BL II at Week 32 |
---|
Double-blind: Placebo | 2.70 | 4.99 | 5.98 | 6.43 | 5.77 | 5.95 | 5.69 | 5.07 | 6.55 |
,Double-blind: Vortioxetine 10 mg | 1.47 | 1.98 | 2.14 | 1.92 | 2.08 | 1.86 | 2.19 | 2.72 | 2.58 |
,Double-blind: Vortioxetine 20 mg | 2.29 | 2.48 | 2.97 | 2.79 | 3.14 | 3.18 | 3.16 | 3.20 | 2.97 |
,Double-blind: Vortioxetine 5 mg | 2.23 | 2.56 | 3.03 | 3.51 | 3.73 | 3.34 | 3.78 | 3.18 | 3.46 |
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Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 (LOCF)
The CGI-I assesses the participant's state of mental illness improvement. The participant's condition compared to baseline is rated on a seven-point scale (1=very much improved ~ 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. (NCT02389816)
Timeframe: Week 8
Intervention | Scores on a scale (Least Squares Mean) |
---|
Placebo | 2.77 |
Vortioxetine 10 mg | 2.42 |
Vortioxetine 20 mg | 2.38 |
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Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Week 8
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension). MADRS corresponds to core symptoms of depression, and rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. (NCT02389816)
Timeframe: Baseline (At the start of double-blind treatment period), up to 8 weeks
Intervention | Scores on a scale (Least Squares Mean) |
---|
Placebo | -12.37 |
Vortioxetine 10 mg | -15.03 |
Vortioxetine 20 mg | -15.45 |
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score to Week 8 (LOCF)
The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. (NCT02389816)
Timeframe: Baseline (At the start of double-blind treatment period), up to 8 weeks
Intervention | Scores on a scale (Least Squares Mean) |
---|
Placebo | -2.85 |
Vortioxetine 10 mg | -4.20 |
Vortioxetine 20 mg | -4.43 |
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MADRS Remission at Week 8 (LOCF)
Reported data was percentage of participants who met MADRS remission criteria (defined as a MADRS total score ≤10) at Week 8 for each group. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension). MADRS corresponds to core symptoms of depression, and rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. (NCT02389816)
Timeframe: Week 8
Intervention | Percentage of Participants (Number) |
---|
Placebo | 21.1 |
Vortioxetine 10 mg | 32.1 |
Vortioxetine 20 mg | 30.9 |
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MADRS Response at Week 8 (Last Observation Carried Forward (LOCF))
Reported data was percentage of participants who met MADRS response criteria (defined as a ≥50% decrease in the MADRS total score from Baseline) at Week 8 for each group. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension). MADRS corresponds to core symptoms of depression, and rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. (NCT02389816)
Timeframe: Week 8
Intervention | Percentage of Participants (Number) |
---|
Placebo | 36.6 |
Vortioxetine 10 mg | 47.9 |
Vortioxetine 20 mg | 50.6 |
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Change From Baseline in Perceived Deficits Questionnaire (PDQ-5) Total Score to Week 8 (LOCF)
PDQ-5 is a self-administered 5-item questionnaire to assess cognition function, including subscales of attention/concentration, retrospective memory, prospective memory, and planning/organization. PDQ-5 total score ranges from 0 to 20 with smaller scores indicate greater cognitive function. (NCT02389816)
Timeframe: Baseline (At the start of double-blind treatment period), up to 8 weeks
Intervention | Scores on a scale (Least Squares Mean) |
---|
Placebo | -1.41 |
Vortioxetine 10 mg | -2.28 |
Vortioxetine 20 mg | -2.69 |
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Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score to Week 8 (LOCF)
The CGI-S assesses the impression of the participant's current state of mental illness. The current severity of mental illness is rated on a seven-point scale (1=normal, not ill at all ~ 7=most extremely ill) based on a total clinical experience. Higher scores indicate greater severity of mental illness. (NCT02389816)
Timeframe: Baseline (At the start of double-blind treatment period), up to 8 weeks
Intervention | Scores on a scale (Least Squares Mean) |
---|
Placebo | -1.19 |
Vortioxetine 10 mg | -1.42 |
Vortioxetine 20 mg | -1.48 |
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Change From Baseline in Digit Symbol Substitution Test (DSST) Total Score to Week 8 (LOCF)
The DSST is a neuropsychological test to assess cognitive function. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. (NCT02389816)
Timeframe: Baseline (At the start of double-blind treatment period), up to 8 weeks
Intervention | Scores on a scale (Least Squares Mean) |
---|
Placebo | 4.92 |
Vortioxetine 10 mg | 4.13 |
Vortioxetine 20 mg | 4.80 |
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Change From Baseline in Hamilton Depression Scale (HAM-D17) Total Score to Week 8 (LOCF)
The HAM-D17 is a clinician-rated scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 where a higher score indicates a greater depressive state. (NCT02389816)
Timeframe: Baseline (At the start of double-blind treatment period), up to 8 weeks
Intervention | Scores on a scale (Least Squares Mean) |
---|
Placebo | -8.38 |
Vortioxetine 10 mg | -10.19 |
Vortioxetine 20 mg | -10.17 |
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Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating
A clinician-administered scale assessing binge eating severity that will be assessed at all 9 study visits. Scores range from 0-40 with higher scores indicating more severe OCD symptoms. (NCT02528409)
Timeframe: 12 weeks
Intervention | units on a scale (Mean) |
---|
| Pre-Treatment | Post-Treatment |
---|
Placebo | 20.10 | 10.44 |
,Vortioxetine | 20.55 | 9.94 |
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Change in Number of Binge Eating Episodes
Subjects will report the number of binge eating episodes in the week preceding the final visit (Week 12 of treatment), both to the investigator and via daily eating journals at all 9 visits. The outcome measure was the change in number of episodes from Week 0 (baseline) to the final visit (Week 12). (NCT02528409)
Timeframe: 12 weeks
Intervention | binge eating episodes (Mean) |
---|
Placebo | .93 |
Vortioxetine | .76 |
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BMI
Assessment of change in patient body mass index over the course of the study (from baseline to the final visit at Week 12). (NCT02528409)
Timeframe: 12 weeks
Intervention | kg/m^2 (Mean) |
---|
| Pre-Treatment | Post-Treatment |
---|
Placebo | 36.19 | 36.29 |
,Vortioxetine | 38.39 | 38.73 |
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Clinical Global Impression Improvement Scale (CGI)
Patient global improvement relative to baseline, with scores ranging from 1-7. Higher scores indicate the patient is doing severely worse than they were at the beginning of treatment. (NCT02528409)
Timeframe: Week 12 (final) visit
Intervention | units on a scale (Mean) |
---|
| Pre-Treatment | Post-Treatment |
---|
Placebo | 4.18 | 2.79 |
,Vortioxetine | 4.25 | 2.70 |
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Hamilton Anxiety Rating Scale
A clinician-administered assessment of anxiety that will be assessed at all 9 study visits. The scale provides a discrete score that ranges from 0-56, with higher scores indicating more severe anxiety symptoms. (NCT02528409)
Timeframe: 12 weeks
Intervention | units on a scale (Mean) |
---|
| Pre-Treatment | Post-Treatment |
---|
Placebo | 4.13 | 1.79 |
,Vortioxetine | 3.68 | 2.72 |
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Hamilton Depression Rating Scale
A clinician-administered assessment of depression that will be assessed at all 8 study visits after the baseline visit. The scale provides a discrete score that ranges from 0-52, with higher scores indicating more severe depressive symptoms. (NCT02528409)
Timeframe: 12 weeks
Intervention | units on a scale (Mean) |
---|
| Pre-Treatment | Post-Treatment |
---|
Placebo | 4.55 | 2.06 |
,Vortioxetine | 4.32 | 3.66 |
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Number of Participants With 4-week Cessation From Binge Eating
Subjects will be assessed at 4 weeks to determine cessation of binge eating status. (NCT02528409)
Timeframe: 4 weeks
Intervention | Participants (Count of Participants) |
---|
| No 4-Week Cessation | 4-Week Cessation |
---|
Placebo | 27 | 10 |
,Vortioxetine | 26 | 13 |
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Quality of Life Inventory
A self-report assessment of patient perceived quality of life that will be assessed at baseline and final visit. The scale provides a discrete score ranging from -192 to 192, with higher numbers indicating higher subjective quality of life. (NCT02528409)
Timeframe: 12 weeks
Intervention | units on a scale (Mean) |
---|
| Pre-Treatment | Post-Treatment |
---|
Placebo | 39.13 | 46.22 |
,Vortioxetine | 35.00 | 44.00 |
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Three-Factor Eating Questionnaire
A self-reported measure of binge eating behavior that will be collected at all 9 study visits with scores ranging from 0-51, with higher scores indicating more compulsive eating habits. (NCT02528409)
Timeframe: 12 weeks
Intervention | units on a scale (Mean) |
---|
| Pre-Treatment | Post-Treatment |
---|
Placebo | 7.71 | 9.85 |
,Vortioxetine | 6.92 | 9.48 |
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Change Clinician Administered PTSD Scale Score
Clinician-Administered PTSD Scale (CAPS-5) has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity. (NCT02637895)
Timeframe: Baseline, Up to Week 12
Intervention | score on a scale (Mean) |
---|
Placebo | 16 |
Vortioxetine | 17 |
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Change in Depressive Symptoms in PTSD
Montgomery-Asberg Depression Rating Scale (MADRS) has a total score ranging from 0-60, with 0 meaning no depressive symptoms and 60 meaning severe depressive symptoms.(MADRS). From the total score 0-60, with 0 meaning no depressive symptoms and 60 meaning severe depressive symptoms. (NCT02637895)
Timeframe: Baseline, Up to Week 12
Intervention | score on a scale (Mean) |
---|
Placebo | 9.73 |
Vortioxetine | 12.06 |
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Number of Participants That Achieve Treatment Response Via CGI-I
Clinical Global Impression of Improvement (CGI-I) is a 7 point Likert-scale questionnaire assessing PTSD symptoms improvement. A score of 1 indicates very much improved, 4 indicates no change and 7 indicates much worse. Treatment response will be reported as the number of participants with an improvement of 1-2 points on their CGI-I score from baseline. Analysis includes observed cases only. (NCT02637895)
Timeframe: Week 12
Intervention | Participants (Count of Participants) |
---|
Placebo | 10 |
Vortioxetine | 11 |
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Number of Participants That Achieve Treatment Response Via Clinician Administered PTSD Scale (CAPS)-5
Number of participants that achieve treatment response will be reported as those that has achieved a 30% improvement in their CAPS-5 total score from baseline. CAPS-5 has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity. Observed cases only. (NCT02637895)
Timeframe: Week 12
Intervention | Participants (Count of Participants) |
---|
Placebo | 9 |
Vortioxetine | 11 |
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Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B
The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows subjects to summarize their experience in a global rating. Item 15 is rated on a 5-point scale from 1 (very poor) to 5 (very good). (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | 0.24 | 0.45 |
,Double-Blind: Placebo | 0.28 | 0.41 |
,Double-Blind: Vortioxetine 10 mg | 0.37 | 0.49 |
,Double-Blind: Vortioxetine 20 mg | 0.43 | 0.52 |
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Clinical Global Impression - Global Improvement (CGI-I) Score
The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT02709655)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | 3.72 | 3.26 | 3.23 | 2.97 | 2.78 | 2.57 |
,Double-Blind: Placebo | 3.66 | 3.32 | 3.20 | 2.93 | 2.70 | 2.69 |
,Double-Blind: Vortioxetine 10 mg | 3.63 | 3.30 | 3.20 | 2.93 | 2.64 | 2.58 |
,Double-Blind: Vortioxetine 20 mg | 3.60 | 3.19 | 3.14 | 2.82 | 2.65 | 2.60 |
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Parent Global Assessment (PGA) Score
The PGA is a parent-rated variation of the CGI-I to evaluate the severity of the child's symptoms. The PGA reflects assessments of symptoms using a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT02709655)
Timeframe: Weeks 2, 4, 6, and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | 3.13 | 2.90 | 2.80 | 2.59 |
,Double-Blind: Placebo | 3.31 | 2.97 | 2.73 | 2.68 |
,Double-Blind: Vortioxetine 10 mg | 3.25 | 2.90 | 2.73 | 2.62 |
,Double-Blind: Vortioxetine 20 mg | 3.18 | 2.84 | 2.68 | 2.61 |
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Percentage of Participants With CDRS-R Remission
CDRS-R remission was defined as a CDRS-R total score ≤28. The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). (NCT02709655)
Timeframe: Weeks 2, 4, 6, and 8 of Phase B
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | 3.8 | 9.0 | 14.1 | 26.9 |
,Double-Blind: Placebo | 2.0 | 9.0 | 14.7 | 14.7 |
,Double-Blind: Vortioxetine 10 mg | 5.4 | 9.5 | 15.4 | 16.7 |
,Double-Blind: Vortioxetine 20 mg | 2.7 | 10.1 | 15.3 | 20.1 |
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Percentage of Participants With CGI-S Remission
CGI-S remission was defined as a CGI-S score of 1 or 2. The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). (NCT02709655)
Timeframe: Weeks 1, 2, 3, 4, 6, and 8 of Phase B
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | 0 | 3.7 | 7.4 | 12.3 | 14.8 | 29.6 |
,Double-Blind: Placebo | 0 | 0.7 | 3.3 | 8.5 | 14.4 | 22.9 |
,Double-Blind: Vortioxetine 10 mg | 0.7 | 3.4 | 4.1 | 8.1 | 16.2 | 22.3 |
,Double-Blind: Vortioxetine 20 mg | 0 | 1.4 | 4.7 | 12.8 | 16.2 | 20.9 |
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Percentage of Participants With CDRS-R Response
CDRS-R response was defined as a ≥50% decrease in CDRS-R total score, calculated as: (change from baseline [Randomization])/(baseline value - 17). The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). (NCT02709655)
Timeframe: Weeks 2, 4, 6, and 8 of Phase B
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | 16.3 | 26.9 | 33.3 | 47.4 |
,Double-Blind: Placebo | 7.8 | 20.7 | 30.8 | 29.4 |
,Double-Blind: Vortioxetine 10 mg | 10.2 | 23.4 | 31.6 | 36.4 |
,Double-Blind: Vortioxetine 20 mg | 11.6 | 26.6 | 37.2 | 41.0 |
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Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was estimated using a restricted maximum likelihood (REML)-based Mixed Model Repeated Measurements (MMRM) approach. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Week 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
Double-Blind: Placebo | -17.48 |
Double-Blind: Vortioxetine 10 mg | -19.20 |
Double-Blind: Vortioxetine 20 mg | -19.94 |
Double-Blind: Fluoxetine 20 mg | -20.78 |
Vortioxetine Average (Avg. VOR) | -19.57 |
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Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B
The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). Four subscores were defined based on the CDRS-R: Mood: sum of items 8, 11, 14, 15; score range 4 to 28, Somatic: sum of items 4, 5, 6, 7, 16, 17; score range 6 to 36, Subjective: sum of items 9, 10, 12, 13; score range 4 to 28, and Behaviour: sum of items 1, 2, 3; score range 3 to 21. Higher scores indicated the most severe measure of depression. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Mood Score: Change at Week 2 | Mood Score: Change at Week 4 | Mood Score: Change at Week 6 | Mood Score: Change at Week 8 | Somatic Score: Change at Week 2 | Somatic Score: Change at Week 4 | Somatic Score: Change at Week 6 | Somatic Score: Change at Week 8 | Subjective Score: Change at Week 2 | Subjective Score: Change at Week 4 | Subjective Score: Change at Week 6 | Subjective Score: Change at Week 8 | Behaviour Score: Change at Week 2 | Behaviour Score: Change at Week 4 | Behaviour Score: Change at Week 6 | Behaviour Score: Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -3.02 | -3.73 | -4.97 | -5.84 | -3.02 | -4.26 | -5.57 | -6.44 | -1.56 | -2.17 | -2.38 | -2.65 | -2.61 | -3.80 | -4.80 | -5.83 |
,Double-Blind: Placebo | -2.82 | -3.69 | -4.67 | -5.08 | -2.81 | -4.08 | -4.86 | -5.38 | -1.44 | -2.04 | -2.43 | -2.56 | -2.16 | -3.39 | -4.09 | -4.47 |
,Double-Blind: Vortioxetine 10 mg | -3.10 | -4.39 | -5.39 | -5.64 | -2.61 | -4.30 | -5.53 | -6.15 | -1.46 | -2.12 | -2.42 | -2.59 | -2.40 | -3.77 | -4.31 | -4.80 |
,Double-Blind: Vortioxetine 20 mg | -3.47 | -4.77 | -5.52 | -5.95 | -2.88 | -4.70 | -5.33 | -6.08 | -1.43 | -2.20 | -2.65 | -2.84 | -2.56 | -4.00 | -4.83 | -5.09 |
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Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 2, 4, and 6 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 6 |
---|
Double-Blind: Fluoxetine 20 mg | -10.17 | -13.97 | -17.75 |
,Double-Blind: Placebo | -9.20 | -13.15 | -16.00 |
,Double-Blind: Vortioxetine 10 mg | -9.54 | -14.56 | -17.64 |
,Double-Blind: Vortioxetine 20 mg | -10.30 | -15.62 | -18.28 |
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Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B
The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally-oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The score ranges from 1 (most functionally impaired child) to 100 (the healthiest). A score greater than 70 indicates normal function. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | 10.54 | 16.35 |
,Double-Blind: Placebo | 8.93 | 12.71 |
,Double-Blind: Vortioxetine 10 mg | 9.84 | 12.98 |
,Double-Blind: Vortioxetine 20 mg | 8.73 | 13.22 |
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Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 3, 4, 6, and 8 of Phase B
The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 1, 2, 3, 4, 6, and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 1 | Change at Week 2 | Change at Week 3 | Change at Week 4 | Change at Week 6 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -0.22 | -0.63 | -0.77 | -1.01 | -1.23 | -1.57 |
,Double-Blind: Placebo | -0.25 | -0.50 | -0.67 | -0.95 | -1.13 | -1.31 |
,Double-Blind: Vortioxetine 10 mg | -0.27 | -0.60 | -0.62 | -1.00 | -1.22 | -1.40 |
,Double-Blind: Vortioxetine 20 mg | -0.28 | -0.65 | -0.79 | -1.06 | -1.27 | -1.44 |
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Change From Baseline in General Behaviour Inventory (GBI) Depression Subscale Score, Using the 10-Item Depression Subscale Assessed by Parent (PGBI-10D) and Child (CGBI-10D) at Weeks 2, 4, 6, and 8 of Phase B
The GBI 10-item depression scale was developed to screen for depressive symptoms in children and adolescents. Two versions of the GBI 10-item depression scale were used, the child rated version (CGBI) and the parent rated version (PGBI). The 10 depression items were rated on a 4-point scale from 0 (never or hardly ever) to 3 (very often or almost constantly). The total score ranged from 0 to 30, with higher scores indicating greater pathology. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| PGBI: Change at Week 2 | PGBI: Change at Week 4 | PGBI: Change at Week 6 | PGBI: Change at Week 8 | CGBI: Change at Week 2 | CGBI: Change at Week 4 | CGBI: Change at Week 6 | CGBI: Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -3.78 | -4.45 | -6.05 | -6.56 | -2.94 | -3.16 | -5.14 | -5.46 |
,Double-Blind: Placebo | -3.33 | -4.11 | -5.32 | -5.81 | -2.66 | -3.65 | -4.62 | -5.26 |
,Double-Blind: Vortioxetine 10 mg | -3.38 | -4.72 | -5.58 | -6.51 | -3.32 | -4.15 | -5.43 | -6.12 |
,Double-Blind: Vortioxetine 20 mg | -3.78 | -5.33 | -5.82 | -6.46 | -3.27 | -4.16 | -5.17 | -5.48 |
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Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Weeks 4 and 8 of Phase B
The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows subjects to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | 4.36 | 6.79 |
,Double-Blind: Placebo | 3.94 | 6.22 |
,Double-Blind: Vortioxetine 10 mg | 4.90 | 7.08 |
,Double-Blind: Vortioxetine 20 mg | 4.90 | 7.14 |
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Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score at Weeks 4 and 8 of Phase B
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -0.41 | -1.08 |
,Double-Blind: Placebo | -0.48 | -0.73 |
,Double-Blind: Vortioxetine 10 mg | -0.51 | -1.07 |
,Double-Blind: Vortioxetine 20 mg | -0.48 | -1.01 |
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Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The average emotional distress summary score is the mean of the anxiety, sadness, anger, and worry items. A lower value represents a better outcome. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -1.13 | -1.66 |
,Double-Blind: Placebo | -0.84 | -1.22 |
,Double-Blind: Vortioxetine 10 mg | -1.28 | -1.80 |
,Double-Blind: Vortioxetine 20 mg | -1.22 | -1.51 |
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Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using visual analogue scales. The functionality for each domain is measured on a 10cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The total score is the average of all 6 items. A lower value represents a better outcome. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -1.01 | -1.54 |
,Double-Blind: Placebo | -0.81 | -1.17 |
,Double-Blind: Vortioxetine 10 mg | -1.19 | -1.55 |
,Double-Blind: Vortioxetine 20 mg | -1.17 | -1.47 |
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Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -1.22 | -1.67 |
,Double-Blind: Placebo | -0.98 | -1.24 |
,Double-Blind: Vortioxetine 10 mg | -1.36 | -1.98 |
,Double-Blind: Vortioxetine 20 mg | -1.33 | -1.36 |
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Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -0.50 | -0.69 |
,Double-Blind: Placebo | -0.22 | -0.70 |
,Double-Blind: Vortioxetine 10 mg | -0.81 | -0.79 |
,Double-Blind: Vortioxetine 20 mg | -0.45 | -1.02 |
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Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -1.42 | -2.31 |
,Double-Blind: Placebo | -1.20 | -1.72 |
,Double-Blind: Vortioxetine 10 mg | -1.65 | -2.23 |
,Double-Blind: Vortioxetine 20 mg | -1.78 | -2.05 |
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Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -0.94 | -1.73 |
,Double-Blind: Placebo | -1.22 | -1.39 |
,Double-Blind: Vortioxetine 10 mg | -1.19 | -1.32 |
,Double-Blind: Vortioxetine 20 mg | -1.63 | -1.74 |
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Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709655)
Timeframe: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Double-Blind: Fluoxetine 20 mg | -1.27 | -1.41 |
,Double-Blind: Placebo | -0.63 | -1.08 |
,Double-Blind: Vortioxetine 10 mg | -1.48 | -1.82 |
,Double-Blind: Vortioxetine 20 mg | -1.21 | -1.45 |
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Change in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Scores
PQ-LES-Q total score (items 1 to 14). The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), which is used to measure quality of life in adults. The PQ LES Q consist of 15 items, item 1-14 assess the degree of satisfaction experienced by subjects in various areas of daily functioning (and item 15 allows subjects to summarize their experience in a global rating). Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1-14 (this outcome measurement) is 14 to 70, with higher scores indicating greater satisfaction. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | 7.62 |
Vortioxetine 20 mg/Day | 7.56 |
Fluoxetine 20 mg/Day, | 9.26 |
Placebo | 7.06 |
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Change in PedsQL VAS: Tired (Fatigue) Score
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709746)
Timeframe: From Randomization to week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -1.18 |
Vortioxetine 20 mg/Day | -1.40 |
Fluoxetine 20 mg/Day, | -1.55 |
Placebo | -1.27 |
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Change in PedsQL VAS: Worry Score
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -0.96 |
Vortioxetine 20 mg/Day | -1.17 |
Fluoxetine 20 mg/Day, | -0.91 |
Placebo | -1.33 |
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Change General Behaviour Inventory (GBI) Depression Subscale Score Assessed by the Child
The GBI 10-item mania scale is a parent- and subject-rated scale designed to screen for manic symptoms in children and adolescents. The 10 items are rated on a scale from 0 (never or hardly ever) to 3 (very often or almost constantly). The total score ranges from 0 to 30 points, with high scores indicating greater pathology. (NCT02709746)
Timeframe: From randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -5.48 |
Vortioxetine 20 mg/Day | -5.55 |
Fluoxetine 20 mg/Day, | -6.30 |
Placebo | -6.03 |
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Change in CDRS-R Behaviour Score
Change in Children Depression Rating Scale - Revised (CDRS-R): Behaviour. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. behaviour is one of four subscores defined in the CDRS-R:sum of items 1, 2, 3; score ranges from 3 to 21. The highest possible score indicates the most severe measure of depression. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -4.32 |
Vortioxetine 20 mg/Day | -4.90 |
Fluoxetine 20 mg/Day, | -5.52 |
Placebo | -4.73 |
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Change in CDRS-R Somatic Score
Change in Children Depression Rating Scale - Revised (CDRS-R): Somatic. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Somatic is one of four subscores defined in the CDRS-R: sum of items 4, 5, 6, 7, 16, 17; score ranges from 6 to 36. The highest possible score indicates the most severe measure of depression. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -5.63 |
Vortioxetine 20 mg/Day | -6.03 |
Fluoxetine 20 mg/Day, | -6.79 |
Placebo | -5.78 |
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Change in PQ-LES-Q Overall Score
PQ-LES-Q overall evaluation score (item 15). The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1-14 assess the degree of satisfaction experienced by subjects in various areas of daily functioning and item 15 allows subjects to summarize their experience in a global rating (this outcome measurement). Item 15 is rated on a 5-point scale from 1 (very poor) to 5 (very good). (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | 0.54 |
Vortioxetine 20 mg/Day | 0.43 |
Fluoxetine 20 mg/Day, | 0.67 |
Placebo | 0.51 |
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Change in Symbol Digit Modalities Test (SDMT)
The Symbol Digit Modalities Test (SDMT) is a cognitive test designed to assess speed of performance requiring visual perception, spatial decision-making and psychomotor skills. The SDMT consists of 110 geometric symbols that the patient has to substitute with a corresponding digit in a 90-second period. Each correct digit is counted, and the total score ranges from 0 (less than normal functioning) to 110 (greater than normal functioning). (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | 3.75 |
Vortioxetine 20 mg/Day | 2.64 |
Fluoxetine 20 mg/Day, | 2.69 |
Placebo | 2.41 |
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Clinical Global Impression - Global Improvement (CGI-I) Score
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | 2.81 |
Vortioxetine 20 mg/Day | 2.69 |
Fluoxetine 20 mg/Day, | 2.50 |
Placebo | 2.73 |
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Parent Global Assessment-Global Improvement (PGA) Score
The PGA is a parent-rated variation of the CGI-I to evaluate the severity of the child's symptoms. The PGA reflects assessments of change from Baseline symptoms using a 7 point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | 2.80 |
Vortioxetine 20 mg/Day | 2.74 |
Fluoxetine 20 mg/Day, | 2.49 |
Placebo | 2.72 |
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Change in CDRS-R Subjective Score
Change in Children Depression Rating Scale - Revised (CDRS-R): Subjective. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Subjective is one of four subscores defined in the CDRS-R: sum of items 9, 10, 12, 13; score ranges from 4 to 28. The highest possible score indicates the most severe measure of depression. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -2.41 |
Vortioxetine 20 mg/Day | -2.63 |
Fluoxetine 20 mg/Day, | -3.23 |
Placebo | -2.66 |
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Change in CDRS-R Total Score During Treatment (at Week 4)
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression). (NCT02709746)
Timeframe: At week 4
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -14.32 |
Vortioxetine 20 mg/Day | -15.03 |
Fluoxetine 20 mg/Day, | -16.25 |
Placebo | -13.71 |
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Change in CDRS-R Total Score During Treatment (at Week 2)
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).Children and parents answer separately. Rater judges and selects 'Best'. (NCT02709746)
Timeframe: At week 2
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -9.58 |
Vortioxetine 20 mg/Day | -10.15 |
Fluoxetine 20 mg/Day, | -10.34 |
Placebo | -8.83 |
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Change in CDRS-R Total Score During Treatment (at Week 6)
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression). (NCT02709746)
Timeframe: At week 6
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -15.43 |
Vortioxetine 20 mg/Day | -17.78 |
Fluoxetine 20 mg/Day, | -19.20 |
Placebo | -16.71 |
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CDRS-R Remission
Remission is defined as a CDRS-R total score <= 28. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | Participants (Count of Participants) |
---|
Vortioxetine 10 mg/Day | 21 |
Vortioxetine 20 mg/Day | 24 |
Fluoxetine 20 mg/Day, | 32 |
Placebo | 20 |
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CDRS-R Response
Children Depression Rating Scale - Response: defined as a >= 50% decrease in CDRS-R total score, calculated as (change from baseline [Randomization])/(baseline value - 17). (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | Participants (Count of Participants) |
---|
Vortioxetine 10 mg/Day | 53 |
Vortioxetine 20 mg/Day | 60 |
Fluoxetine 20 mg/Day, | 68 |
Placebo | 49 |
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Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression). (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -17.09 |
Vortioxetine 20 mg/Day | -18.94 |
Fluoxetine 20 mg/Day, | -21.95 |
Placebo | -18.22 |
Vortioxetine Average (Avg. VOR) | -18.01 |
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Change in Children's Global Assessment Scale (CGAS) Score
The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children. The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The items range in value from 1 (most functionally impaired child) to 100 (the healthiest). A total score above 70 indicates normal function. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | 12.24 |
Vortioxetine 20 mg/Day | 13.89 |
Fluoxetine 20 mg/Day, | 16.43 |
Placebo | 14.52 |
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Change in Clinical Global Impression Severity of Illness (CGI-S) Score
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -1.23 |
Vortioxetine 20 mg/Day | -1.38 |
Fluoxetine 20 mg/Day, | -1.59 |
Placebo | -1.21 |
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Change in CDRS-R Mood Score
Change in Children Depression Rating Scale - Revised (CDRS-R) Mood. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Mood is one of four subscores defined in the CDRS-R: sum of items 8, 11, 14, 15; score range 4 to 28. The highest possible score indicates the most severe measure of depression. (NCT02709746)
Timeframe: From randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -5.05 |
Vortioxetine 20 mg/Day | -5.47 |
Fluoxetine 20 mg/Day, | -6.53 |
Placebo | -5.32 |
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Change in General Behaviour Inventory (GBI) Depression Sub Scale Score Assessed by the Parents
Using the 10-item depression subscale, assessed by parent (PGBI-10D). Change from randomization to Week 8 in GBI Total Parent/Guardian Version Depression score. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome. (NCT02709746)
Timeframe: From randomization to week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -6.23 |
Vortioxetine 20 mg/Day | -6.48 |
Fluoxetine 20 mg/Day, | -8.00 |
Placebo | -6.62 |
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Change in PedsQL Emotional Distress Summary Average Score
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. The average emotional distress summary score is the mean of the anxiety, sadness, anger, and worry items. A lower value represents a better outcome. (NCT02709746)
Timeframe: From Randomization to week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -0.93 |
Vortioxetine 20 mg/Day | -1.09 |
Fluoxetine 20 mg/Day, | -1.33 |
Placebo | -1.18 |
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CGI-S Remission
Remission defined as CGI-S score of 1 or 2. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | Participants (Count of Participants) |
---|
Vortioxetine 10 mg/Day | 26 |
Vortioxetine 20 mg/Day | 33 |
Fluoxetine 20 mg/Day, | 36 |
Placebo | 24 |
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Change in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -0.47 |
Vortioxetine 20 mg/Day | -0.76 |
Fluoxetine 20 mg/Day, | -0.78 |
Placebo | -0.71 |
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Change in PedsQL VAS Total Average Score
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using visual analogue scales. The functionality for each domain is measured on a 10cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. The total score is the average of all 6 items. A lower value represents a better outcome. (NCT02709746)
Timeframe: From Randomization to week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -1.00 |
Vortioxetine 20 mg/Day | -1.13 |
Fluoxetine 20 mg/Day, | -1.33 |
Placebo | -1.14 |
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Change in PedsQL VAS: Angry Score
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -0.51 |
Vortioxetine 20 mg/Day | -0.70 |
Fluoxetine 20 mg/Day, | -1.01 |
Placebo | -0.59 |
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Change in PedsQL VAS: Pain or Hurt Score
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -1.12 |
Vortioxetine 20 mg/Day | -0.97 |
Fluoxetine 20 mg/Day, | -0.83 |
Placebo | -0.76 |
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Change in PedsQL VAS: Sad or Blue (Sadness) Score
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome. (NCT02709746)
Timeframe: From Randomization to Week 8
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine 10 mg/Day | -1.90 |
Vortioxetine 20 mg/Day | -1.71 |
Fluoxetine 20 mg/Day, | -2.45 |
Placebo | -2.12 |
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Correlations Between BNA Latency Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores
Pearson correlation was used to examine the associations between baseline BNA latency scores and outcomes including measures of MDD symptoms, cognitive function and functionality. (NCT02749721)
Timeframe: Baseline to Endpoint (8 weeks)
Intervention | milliseconds (Mean) |
---|
| AOB P200 latency Baseline | AOB P200 latency Endpoint (8 weeks) | AOB P3a latency Baseline | AOB P3a latency Endpoint (8 weeks) | AOB P3b latency Baseline | AOB P3b latency Endpoint (8 weeks) | VGNG P200 latency Baseline | VGNG P200 latency Endpoint (8 weeks) | VGNG P3a latency Baseline | VGNG P3a latency Endpoint (8 weeks) |
---|
Vortioxetine | 177.37 | 177.90 | 308.47 | 281.38 | 370.07 | 367.27 | 170.35 | 172.11 | 433.75 | 431.44 |
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Changes in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-16-SR) From Baseline to 8 Week Endpoint
The QIDS-16-SR is a 16-item self-rated assessment of the severity of depressive symptoms. The assessments can be used to screen for depression, although they have been used predominantly as measures of symptom severity. The nine domains comprise 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease or increase in appetite or weight; and 9) psychomotor agitation or retardation. The total score ranges from 0 to 27 with higher scores equating to more severe symptomatology. The seven day period prior to assessment is the usual time frame for assessing symptom severity. (NCT02749721)
Timeframe: Baseline to endpoint (week 8)
Intervention | score on a scale (Mean) |
---|
| Baseline | Endpoint (week 8) |
---|
Vortioxetine | 16.24 | 7.91 |
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Changes in Hamilton Depression Rating Scale (HDRS) 28 From Baseline to 8 Week Endpoint
The HDRS is a clinician-rated used to rate the patient's depressive state. The 17 question version of the scale rates depressive state based on feelings of depression, guilt, suicidality, anxiety, agitation, somatic symptoms, level of insight, patterns of insomnia, loss of interest in work and other activities, weight loss, and hypochondriasis. Additionally, the 28 question version rates depersonalization, paranoia, obsessions/compulsions, hypersomnia, appetite increase, and psychomotor slowing. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54 for the 17 question version and 0 to 83 for the 28 question version. Scores between 0 and 6 do not indicate the presence of depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression. (NCT02749721)
Timeframe: Baseline to endpoint (week 8)
Intervention | score on a scale (Mean) |
---|
| Baseline | Endpoint (week 8) |
---|
Vortioxetine | 28.44 | 14.77 |
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Changes in Hamilton Depression Rating Scale (HDRS) 17 From Baseline to 8 Week Endpoint
The HDRS is a clinician-rated used to rate the patient's depressive state. The 17 question version of the scale rates depressive state based on feelings of depression, guilt, suicidality, anxiety, agitation, somatic symptoms, level of insight, patterns of insomnia, loss of interest in work and other activities, weight loss, and hypochondriasis. Additionally, the 28 question version rates depersonalization, paranoia, obsessions/compulsions, hypersomnia, appetite increase, and psychomotor slowing. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54 for the 17 question version and 0 to 83 for the 28 question version. Scores between 0 and 6 do not indicate the presence of depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression. (NCT02749721)
Timeframe: Baseline to endpoint (week 8)
Intervention | score on a scale (Mean) |
---|
| Baseline | Endpoint (week 8) |
---|
Vortioxetine | 23.76 | 11.59 |
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Changes in Clinical Global Impression Scale (CGI-S) From Baseline to 8 Week Endpoint
The CGI-S assesses the clinician's impression of the subject's current mental illness state (considering their total clinical experience with this particular population) via 7 point scale (ranging from 1-7) with higher scores equating to more symptoms. For example, a score of 1 = normal, not at all ill and a score of 7 = severely ill. (NCT02749721)
Timeframe: Baseline to endpoint (week 8)
Intervention | score on a scale (Mean) |
---|
| Baseline | Endpoint (week 8) |
---|
Vortioxetine | 4.88 | 2.64 |
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Change in Montgomery and Asberg Depression Rating Scale (MADRS)
The MADRS is a 10-item rating scale designed to assess the severity of symptoms of depression. Range is 0-60. Higher score means more severe. (NCT02749721)
Timeframe: from baseline to endpoint (up to 8 weeks)
Intervention | score on a scale (Mean) |
---|
| Baseline | Week 8 |
---|
Vortioxetine | 33.28 | 16.23 |
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Change From Baseline to Endpoint in Digital Symbol Substitution Test.
Change in cognitive function defined as change from baseline to endpoint. The Digital Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making and motor skills. The DSST consists of 133 digits and requires the subject to substitute each digit with a simple symbol in a 90-second period. The number of correct symbols within the allowed time (eg, 90 sec) is measured. It takes approximately 5 minutes to complete and score the DSST. (NCT02749721)
Timeframe: Baseline to endpoint (week 8)
Intervention | number of correct symbols within 90 sec (Mean) |
---|
| Baseline | Endpoint (week 8) |
---|
Vortioxetine | 48.24 | 55.55 |
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BNA Scores Latencies
Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds). (NCT02749721)
Timeframe: Baseline to Endpoint (8 weeks)
Intervention | milliseconds (Mean) |
---|
| AOB P200 latency Baseline | AOB P200 latency Endpoint (8 weeks) | AOB P3a latency Baseline | AOB P3a latency Endpoint (8 weeks) | AOB P3b latency Baseline | AOB P3b latency Endpoint (8 weeks) | VGNG P200 latency Baseline | VGNG P200 latency Endpoint (8 weeks) | VGNG P3a latency Baseline | VGNG P3a latency Endpoint (8 weeks) |
---|
Vortioxetine | 177.37 | 177.90 | 308.47 | 281.38 | 370.07 | 367.27 | 170.35 | 172.11 | 433.75 | 431.44 |
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Correlations Between BNA Amplitude Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores
Pearson correlation was used to examine the associations between baseline BNA amplitude scores and outcomes including measures of MDD symptoms, cognitive function and functionality. (NCT02749721)
Timeframe: Baseline to Endpoint (8 weeks)
Intervention | microvolts (Mean) |
---|
| AOB P200 amplitude Baseline | AOB P200 amplitude Endpoint (8 weeks) | AOB P3a amplitude Baseline | AOB P3a amplitude Endpoint (8 weeks) | AOB P3b amplitude Baseline | AOB P3b amplitude Endpoint (8 weeks) | VGNG P200 amplitude Baseline | VGNG P200 amplitude Endpoint (8 weeks) | VGNG P3a amplitude Baseline | VGNG P3a amplitude Endpoint (8 weeks) |
---|
Vortioxetine | 4.04 | 3.96 | 9.43 | 7.13 | 6.48 | 6.75 | 3.40 | 3.66 | 3.33 | 3.55 |
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BNA Scores Amplitudes
Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds). (NCT02749721)
Timeframe: Baseline to Endpoint (8 weeks)
Intervention | microvolts (Mean) |
---|
| AOB P200 amplitude Baseline | AOB P200 amplitude Endpoint (8 weeks) | AOB P3a amplitude Baseline | AOB P3a amplitude Endpoint (8 weeks) | AOB P3b amplitude Baseline | AOB P3b amplitude Endpoint (8 weeks) | VGNG P200 amplitude Baseline | VGNG P200 amplitude Endpoint (8 weeks) | VGNG P3a amplitude Baseline | VGNG P3a amplitude Endpoint (8 weeks) |
---|
Vortioxetine | 4.04 | 3.96 | 9.43 | 7.13 | 6.48 | 6.75 | 3.40 | 3.66 | 3.33 | 3.55 |
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Clinical Global Impression - Global Improvement (CGI-I) Score
The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). LS mean was calculated using a restricted maximum likelihood-based MMRM approach. (NCT02871297)
Timeframe: Week 26
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine | 1.72 |
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Adolescents (12-18 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Self-report (BRIEF-SR) Using the GEC Score at Week 26
"BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 never, 2 sometimes or 3 often. These items cover 8 non-overlapping clinical scales. For BRIEF-SR form, only 80 items (Inhibit [13], Shift [10], Emotional Control [10], Initiate [5], Working Memory [12], Plan/Organize [13], Organization of Materials [7], Monitor [10]) were included in clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI, and 1 composite summary score, the GEC, that incorporates all 8 clinical scales. GEC score was calculated as the sum of index scores and ranges from 80-240 with higher scores indicating greater impairment in functions. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-SR. The conversion was based on gender and the age group. T-scores ranged between 29 to 104, with a lower score indicating better functioning." (NCT02871297)
Timeframe: Baseline, Week 26
Intervention | T score (Mean) |
---|
Vortioxetine | -7.50 |
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Number of Participants With Response to the Palatability Questionnaire
The palatability of vortioxetine oral drops was assessed after intake of a single dose (5 to 20 mg) corresponding to the participant's current vortioxetine dose (replacing the vortioxetine tablet on that day). The palatability assessment included 4 questions on the overall appreciation of a medicinal product in relation to its taste (What do you think of the taste), mouthfeel (How does medicine feel in your mouth), aftertaste (What do you think of the after taste), and smell (What do you think of the smell). The items were rated on a 5-point hedonic scale; really bad, bad, neither good or bad, good, or very good. The oral drops were considered acceptable if the mean hedonic scores were ≤3 for each aspect of palatability (taste, aftertaste, smell, and mouthfeel). (NCT02871297)
Timeframe: assessed at Baseline up to Week 26, Week 26 reported
Intervention | Participants (Count of Participants) |
---|
| Mouthfeel72526170 | Aftertaste72526170 | Smell72526170 | Taste72526170 |
---|
| Bad | Neither good or bad | Good | Really bad | Very good |
---|
Vortioxetine | 11 |
Vortioxetine | 17 |
Vortioxetine | 38 |
Vortioxetine | 55 |
Vortioxetine | 26 |
Vortioxetine | 54 |
Vortioxetine | 28 |
Vortioxetine | 4 |
Vortioxetine | 37 |
Vortioxetine | 59 |
Vortioxetine | 49 |
Vortioxetine | 13 |
Vortioxetine | 15 |
Vortioxetine | 33 |
Vortioxetine | 60 |
Vortioxetine | 32 |
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Number of Participants With Response to the Acceptability Questionnaire
"The acceptability of vortioxetine oral drops was assessed after intake of a single dose (5 to 20 mg) corresponding to the participant's current vortioxetine dose (replacing the vortioxetine tablet on that day). The acceptability assessment was based on 3 items; acceptability of the taste, whether the drops were perceived as easy to take, willingness to take the drops every day (provided it was the only available formulation). For each item the response options were no, not sure, and yes. The oral drops were considered acceptable if <60% of participants responded no to each of the 3 questions regarding acceptability." (NCT02871297)
Timeframe: assessed at Baseline up to Week 26, Week 26 reported
Intervention | participants (Number) |
---|
| Willingness to take the drops every day: No | Willingness to take the drops every day: Not sure | Willingness to take the drops every day: Yes | Easy to take medicine: No | Easy to take medicine: Neither easy or difficult | Easy to take medicine: Yes | Acceptability of the taste: No | Acceptability of the taste: Not sure | Acceptability of the taste: Yes |
---|
Vortioxetine | 27 | 17 | 109 | 8 | 10 | 135 | 31 | 24 | 98 |
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Children (7-11 Years): Change From Baseline in BRIEF-P Using the MI Score at Week 26
"BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 never, 2 sometimes or 3 often. These items cover 8 non-overlapping clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI. For BRIEF-P, MI is comprised of Initiate (8), Working Memory (10), Plan/Organize (12), Organization of Materials (6), and Monitor (8) scales. The MI scores are calculated as the sum of the total 44 items ranging from 44 to 132 with lower scores reflecting better functioning. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-P. The conversion was based on gender and the age group. T-scores ranged between 30 to 98, with a lower score indicating better functioning." (NCT02871297)
Timeframe: Baseline, Week 26
Intervention | T score (Mean) |
---|
Vortioxetine | -7.36 |
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Children (7-11 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Preschool (BRIEF-P) Using the Global Executive Composite (GEC) Score at Week 26
"BRIEF form is an 86-item measure with symptoms rated on a 3-point likert scale of 1 never, 2 sometimes or 3 often. These items cover 8 non-overlapping clinical scales. For BRIEF-P form, only the first 72 items (Inhibit [10], Shift [8], Emotional Control [10], Initiate [8], Working Memory [10], Plan/Organize [12], Organization of Materials [6], Monitor [8]) were included in clinical scales. Clinical scales combined to form 2 indexes, Behavioural Regulation Index (BRI) and Metacognition Index (MI), and 1 composite summary score, the GEC, that incorporates all 8 clinical scales. GEC score was calculated as the sum of index scores ranging from 72-216; higher scores indicating greater impairment in executive functions. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-P. Conversion was based on gender and age group. T-scores ranged between 30 to 101, with a lower score indicating better functioning." (NCT02871297)
Timeframe: Baseline, Week 26
Intervention | T score (Mean) |
---|
Vortioxetine | -7.41 |
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Change From Baseline in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scale (PedsQL VAS) Total Score at Week 26
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using VAS. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The total score is the average of all 6 items ranging from 0 to 10, where a lower value represents a better outcome. (NCT02871297)
Timeframe: Baseline, Week 26
Intervention | units on a scale (Mean) |
---|
Vortioxetine | -1.50 |
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Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). LS mean was calculated using a restricted maximum likelihood-based MMRM approach. (NCT02871297)
Timeframe: Baseline, Week 26
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine | -1.48 |
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Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Week 26
The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally-oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The score ranges from 1 (most functionally impaired child) to 100 (the healthiest). A score greater than 70 indicates normal function. (NCT02871297)
Timeframe: Baseline, Week 26
Intervention | units on a scale (Mean) |
---|
Vortioxetine | 14.78 |
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Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26
CDRS-R consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. Total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was calculated using a restricted maximum likelihood-based mixed model for repeated measurements (MMRM) approach. (NCT02871297)
Timeframe: Baseline, Week 26
Intervention | units on a scale (Least Squares Mean) |
---|
Vortioxetine | -16.05 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAE was defined as an AE that started or increased in intensity on or after the date of first dose of study drug in this study 12712A. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. (NCT02871297)
Timeframe: Baseline up to Week 30
Intervention | Participants (Count of Participants) |
---|
Vortioxetine | 404 |
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Adolescents (12-18 Years): Change From Baseline in BRIEF-SR Using the MI Score at Week 26
"BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 never, 2 sometimes or 3 often. These items cover 8 non-overlapping clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI. For BRIEF-SR, MI is comprised of Working Memory (12), Plan/Organize (13), Organization of Materials (7), and Task Completion (10) scales. The MI scores are calculated as the sum of the total 42 items ranging from 42 to 126 with lower scores reflecting better functioning. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-SR. The conversion was based on gender and the age group. T-scores ranged between 31 to 100, with a lower score indicating better functioning." (NCT02871297)
Timeframe: Baseline, Week 26
Intervention | T score (Mean) |
---|
Vortioxetine | -7.18 |
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Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS)
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. (NCT02932904)
Timeframe: Baseline and Week 5
Intervention | score on a scale (Least Squares Mean) |
---|
| Baseline | Change from Baseline at Week 5 |
---|
Paroxetine 20 mg | 59.27 | -3.56 |
,Vortioxetine 10 mg | 58.56 | -0.82 |
,Vortioxetine 20 mg | 59.43 | -2.51 |
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Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. (NCT02932904)
Timeframe: Baseline and Week 5
Intervention | score on a scale (Least Squares Mean) |
---|
| Baseline | Change from Baseline at Week 5 |
---|
Paroxetine 20 mg | 59.13 | -4.01 |
,Vortioxetine 10 mg | 58.55 | -0.63 |
,Vortioxetine 20 mg | 59.36 | -2.38 |
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Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. (NCT02932904)
Timeframe: Baseline and Week 5
Intervention | score on a scale (Least Squares Mean) |
---|
| Baseline | Change from Baseline at Week 5 |
---|
Paroxetine 20 mg | 58.73 | -4.78 |
,Vortioxetine 10 mg | 58.53 | -0.47 |
,Vortioxetine 20 mg | 59.23 | -1.72 |
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Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. (NCT02932904)
Timeframe: Baseline and Weeks 1, 2, 3 and 4
Intervention | score on a scale (Least Squares Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 |
---|
Paroxetine 20 mg | -1.67 | -2.40 | -2.77 | -3.11 |
,Vortioxetine 10 mg | -0.54 | -1.18 | -0.77 | -1.20 |
,Vortioxetine 20 mg | -0.38 | -1.55 | -2.36 | -2.43 |
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Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. (NCT02932904)
Timeframe: Baseline and Weeks 1, 2, 3, 4 and 5
Intervention | score on a scale (Least Squares Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 |
---|
Placebo | -0.05 | -1.11 | -0.91 | -0.62 | -0.79 |
,Vortioxetine 10 mg | -0.54 | -1.18 | -0.77 | -1.20 | -0.82 |
,Vortioxetine 20 mg | -0.38 | -1.55 | -2.36 | -2.43 | -2.51 |
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Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5
Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women. (NCT02932904)
Timeframe: Weeks 1, 2, 3, 4 and 5
Intervention | percentage of participants (Number) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 |
---|
Paroxetine 20 mg | 2.4 | 8.4 | 8.4 | 9.6 | 9.6 |
,Placebo | 2.2 | 7.9 | 4.5 | 4.5 | 3.4 |
,Vortioxetine 10 mg | 1.2 | 3.5 | 3.5 | 4.7 | 5.9 |
,Vortioxetine 20 mg | 1.1 | 2.2 | 6.6 | 7.7 | 9.9 |
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Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. (NCT02932904)
Timeframe: Baseline and Weeks 1, 2, 3, 4 and 5
Intervention | score on a scale (Least Squares Mean) |
---|
| Desire Score: Week 1 | Desire Score: Week 2 | Desire Score: Week 3 | Desire Score: Week 4 | Desire Score: Week 5 | Arousal Score: Week 1 | Arousal Score: Week 2 | Arousal Score: Week 3 | Arousal Score: Week 4 | Arousal Score: Week 5 | Orgasm/Completion/Ejaculation Score: Week 1 | Orgasm/Completion/Ejaculation Score: Week 2 | Orgasm/Completion/Ejaculation Score: Week 3 | Orgasm/Completion/Ejaculation Score: Week 4 | Orgasm/Completion/Ejaculation Score: Week 5 |
---|
Paroxetine 20 mg | -0.50 | -0.83 | -1.09 | -1.07 | -1.38 | -0.30 | -0.47 | -0.43 | -0.54 | -0.67 | -0.48 | -0.61 | -0.75 | -1.04 | -1.09 |
,Placebo | 0.09 | -0.40 | -0.50 | -0.36 | -0.42 | -0.01 | -0.34 | -0.22 | -0.11 | -0.19 | -0.12 | -0.21 | -0.20 | -0.14 | -0.12 |
,Vortioxetine 10 mg | -0.23 | -0.34 | -0.22 | -0.37 | -0.19 | -0.05 | -0.35 | -0.08 | -0.10 | -0.03 | -0.22 | -0.26 | -0.33 | -0.45 | -0.42 |
,Vortioxetine 20 mg | -0.14 | -0.68 | -0.77 | -0.77 | -0.82 | -0.03 | -0.30 | -0.51 | -0.54 | -0.54 | -0.15 | -0.37 | -0.67 | -0.72 | -0.79 |
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Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. (NCT02932904)
Timeframe: Baseline and Weeks 1, 2, 3, 4 and 5
Intervention | score on a scale (Least Squares Mean) |
---|
| Pleasure Score: Week 1 | Pleasure Score: Week 2 | Pleasure Score: Week 3 | Pleasure Score: Week 4 | Pleasure Score: Week 5 | Desire/Frequency Score: Week 1 | Desire/Frequency Score: Week 2 | Desire/Frequency Score: Week 3 | Desire/Frequency Score: Week 4 | Desire/Frequency Score: Week 5 | Desire/Interest Score: Week 1 | Desire/Interest Score: Week 2 | Desire/Interest Score: Week 3 | Desire/Interest Score: Week 4 | Desire/Interest Score: Week 5 | Arousal/Excitement/Erection Score: Week 1 | Arousal/Excitement/Erection Score: Week 2 | Arousal/Excitement/Erection Score: Week 3 | Arousal/Excitement/Erection Score: Week 4 | Arousal/Excitement/Erection Score: Week 5 | Orgasm/Completion/Ejaculation Score: Week 1 | Orgasm/Completion/Ejaculation Score: Week 2 | Orgasm/Completion/Ejaculation Score: Week 3 | Orgasm/Completion/Ejaculation Score: Week 4 | Orgasm/Completion/Ejaculation Score: Week 5 |
---|
Paroxetine 20 mg | -0.36 | -0.38 | -0.44 | -0.38 | -0.47 | -0.35 | -0.46 | -0.62 | -0.55 | -0.66 | -0.15 | -0.38 | -0.47 | -0.52 | -0.73 | -0.30 | -0.47 | -0.43 | -0.54 | -0.67 | -0.48 | -0.61 | -0.75 | -1.04 | -1.09 |
,Placebo | -0.07 | -0.26 | -0.23 | -0.18 | -0.21 | -0.03 | -0.30 | -0.33 | -0.25 | -0.28 | 0.12 | -0.09 | -0.16 | -0.11 | -0.14 | -0.01 | -0.34 | -0.22 | -0.11 | -0.19 | -0.12 | -0.21 | -0.20 | -0.14 | -0.12 |
,Vortioxetine 10 mg | -0.13 | -0.25 | -0.18 | -0.31 | -0.16 | -0.07 | -0.25 | -0.23 | -0.20 | -0.15 | -0.16 | -0.11 | -0.01 | -0.18 | -0.05 | -0.05 | -0.35 | -0.08 | -0.10 | -0.03 | -0.22 | -0.26 | -0.33 | -0.45 | -0.42 |
,Vortioxetine 20 mg | -0.15 | -0.26 | -0.42 | -0.37 | -0.33 | -0.23 | -0.46 | -0.50 | -0.43 | -0.49 | 0.09 | -0.22 | -0.28 | -0.35 | -0.33 | -0.03 | -0.30 | -0.51 | -0.54 | -0.54 | -0.15 | -0.37 | -0.67 | -0.72 | -0.79 |
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Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. (NCT02932904)
Timeframe: Baseline and Weeks 1, 2, 3, 4 and 5
Intervention | score on a scale (Least Squares Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 |
---|
Paroxetine 20 mg | -1.67 | -2.40 | -2.77 | -3.11 | -3.56 |
,Placebo | -0.05 | -1.11 | -0.91 | -0.62 | -0.79 |
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Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)
This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome. (NCT02969876)
Timeframe: 6 weeks
Intervention | score on a scale (Mean) |
---|
Study Phase | 12.5 |
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Rey Auditory Verbal Learning Test
A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome (NCT02969876)
Timeframe: 6 weeks
Intervention | number of words recalled (Mean) |
---|
Open Trial Vortioxetine | 54 |
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Digital Symbol Substitution Test
A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome. (NCT02969876)
Timeframe: 6 weeks
Intervention | number of substitutions (Mean) |
---|
Open Trial Vortioxetine | 41.5 |
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Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12
GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at outset of study. Another evaluation took place at EOS visit to determine level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with SD of 10. The total score ranges between 22.6 and 77.4. A positive change from baseline in the composite of 3 goals (50 or above) indicates response. (NCT02972632)
Timeframe: Baseline and Weeks 6 and 12
Intervention | score on a scale (Mean) |
---|
| Baseline | Change at Week 6 | Change at Week 12 |
---|
Vortioxetine | 23.57 | 18.21 | 26.94 |
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Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12
"Q-LES-Q is a scale designed to allow researchers to assess the degree of a participant's quality of life in various areas of daily living. There is not a Total Score per se for the Q-LES-Q. The scale is divided into domains. Ninety-one of the 93 items are assembled into 8 categories: physical health/activities, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. Items are scored on a 5 point scale, from 1 (not at all or never) to 5 (frequently or all the time), to indicate the degree of enjoyment or satisfaction experienced by domain. Raw summary scores are expressed as a percentage of the maximum possible score within a given domain to facilitate comparisons across areas of functioning. The total score is based on the Overall Life Satisfaction question in General Activities and ranges from 1 to 5. A positive change from baseline indicates greater enjoyment/satisfaction." (NCT02972632)
Timeframe: Baseline and Week 12
Intervention | score on a scale (Mean) |
---|
| Baseline | Change at Week 12 |
---|
Vortioxetine | 2.487 | 1.128 |
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Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12
"The PDQ-D is a 20-item, patient-reported questionnaire with a 7-day recall period. Scores for four subscales. All 20 items use the same 5-point ordinal categorical response scale to reflect the frequency of experiencing a specific cognitive problem in the past 7 days. Scores for each of the four measured subscales are calculated by assigning a value of 0 (never in the past 7 days), 1 (rarely - once or twice), 2 (sometimes - 3-5 times), 3 (often - about once a day), or 4 (very often - more than once a day) to each item, then summing the five items of that subscale, to produce a score ranging from 0 to 20. A total global score for overall cognitive dysfunction (range 0-80) is calculated by summing the four subscale scores. Higher scores for each subscale and for the total score indicate greater perceived cognitive dysfunction. A negative change from Baseline indicates improvement." (NCT02972632)
Timeframe: Baseline and Weeks 6 and 12
Intervention | score on a scale (Mean) |
---|
| Baseline | Change at Week 6 | Change at Week 12 |
---|
Vortioxetine | 40.5 | -14.8 | -18.0 |
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Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12
PHQ-9 is a well-established participant reported outcome tool for assessment of change in depressive symptoms and is a sensitive measure of depression severity. The PHQ-9 consists of a 9-item scale originally developed for primary care settings, with 1 item corresponding to each of the 9 made symptom criteria for depression in diagnostic and statistical manual of mental disorders (DSM), asking if they have bothered the participant over the last 2 weeks. Each question is rated on a scale from 0 (not at all) to 3 (nearly every day). If any problems are answered 1 or higher, a final question on how difficult those problems made it to do work, take care of things at home, or get along with other people is completed, rated from not difficult at all to extremely difficult. The 9 questions are summed to a total score ranging from 0 to 27 with higher scores reflecting greater severity. A positive change from baseline indicates severe condition. (NCT02972632)
Timeframe: Baseline and Weeks 6 and 12
Intervention | score on a scale (Mean) |
---|
| Baseline | Change at Week 6 | Change at Week 12 |
---|
Vortioxetine | 15.7 | -6.5 | -8.4 |
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Change From Baseline in Clinical Global Impression Scale Severity (CGI-S) at Week 12
CGI-S is a clinician rated scale designed to assess global severity of illness and change in the clinical condition over time. The CGI-S provides the clinician's impression of the participant's state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's mental illness on a 7-point scale ranging from 1 (normal-not at all ill) to 7 (among the most extremely ill participants). Higher scores indicate greater severity of illness. A negative change from baseline indicates improvement. (NCT02972632)
Timeframe: Baseline and Week 12
Intervention | score on a scale (Mean) |
---|
| Baseline | Change at Week 12 |
---|
Vortioxetine | 4.4 | -1.6 |
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Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12
WHO-5 is a short, self-administered questionnaire covering 5 positively worded items, related to positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things). Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25, with higher score meaning better well-being. A positive change from baseline indicates improvement. (NCT02972632)
Timeframe: Baseline and Week 12
Intervention | score on a scale (Mean) |
---|
| Baseline | Change at Week 12 |
---|
Vortioxetine | 5.6 | 7.2 |
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Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12
GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at the outset of study. Another evaluation took place at end of study (EOS) visit to determine the level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with a standard deviation (SD) of 10. Higher score indicates composite of 3 goals (50 or above) as response. (NCT02972632)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Vortioxetine | 57.8 |
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Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 12
CGI-I assesses the participant's improvement (or worsening). The clinician assessed participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicated greater severity of illness. (NCT02972632)
Timeframe: Week 12
Intervention | score on a scale (Mean) |
---|
Vortioxetine | 2.2 |
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Changes in the World Health Organization Wellbeing Index (5-Item)
The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive questions, which tap into the subjective well-being of the respondents. The WHO-5 only contains positively phrased items. The respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). A percent score out of 25 is reported. (NCT03053362)
Timeframe: Baseline and 8 weeks
Intervention | percent of maximum score (Mean) |
---|
| Week 0 | Week 8 |
---|
Healthy Control Participants | 72.42 | 73.60 |
,Major Depressive Disorder Population | 15.24 | 29.16 |
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Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS)
Changes in mood assessed by the Montgomery Åsberg Depression Rating Scale [MADRS]. The overall score ranges from 0 to 60, where greater scores indicate worse depression. (NCT03053362)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Week 0 | Week 8 |
---|
Healthy Control Participants | 1.64 | 1.02 |
,Major Depressive Disorder Population | 31.83 | 20.39 |
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Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score
Sheehan Disability Scale rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The numerical ratings of 0-10 can be translated into a percentage if desired. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). (NCT03053362)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Week 0 | Week 8 |
---|
Healthy Control Participants | 0.98 | 1.3 |
,Major Depressive Disorder Population | 20.63 | 14.64 |
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Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B)
Changes in cognition assessed by the TMT-B. The outcome measure is time in seconds, where greater time indicates worse performance. (NCT03053362)
Timeframe: Baseline and 8 weeks
Intervention | seconds (Mean) |
---|
| Week 0 | Week 8 |
---|
Healthy Control Participants | 70.60 | 58.71 |
,Major Depressive Disorder Population | 72.95 | 62.72 |
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Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST)
Changes in cognition assessed by the Digit Symbol Substitution Task (DSST). The outcome measure is the number of correct symbols copied by the participants. Higher scores indicate better performance (minimum score is 0 and maximum is 133). (NCT03053362)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Week 0 | Week 8 |
---|
Healthy Control Participants | 61.21 | 67.53 |
,Major Depressive Disorder Population | 56.05 | 64.14 |
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Changes in Changes in Anhedonia From Baseline to Week 8
To establish sensitivity to change in anhedonia using the Snaith-Hamilton Pleasure Scale (SHAPS) total score in adults (18-65) with MDD treated with vortioxetine (10-20 mg flexibly dosed for 8 weeks). Higher score indicates more pleasure, with maximum of 56 points on the scale. (NCT03053362)
Timeframe: Baseline and 8 weeks
Intervention | units on a scale (Mean) |
---|
| Week 0 | Week 8 |
---|
Healthy Control Participants | 51.12 | 50.38 |
,Major Depressive Disorder Population | 35.12 | 40.33 |
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Change in Total Fluid Cognitive Score
"Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured fluid cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment." (NCT03272711)
Timeframe: Randomization (0 weeks), 4 week, 12 week, 26 week
Intervention | score on a scale (Mean) |
---|
| Change at Week 4 | Change at Week 12 | Change at Week 26 | Total Fluid Cognitive Score at Week 4 | Total Fluid Cognitive Score at Week 12 | Total Fluid Cognitive Score at Week 26 |
---|
Placebo Plus Cognitive Training | 3.71 | 3.93 | 6.05 | 105.85 | 105.57 | 107.51 |
,Vortioxetine Plus Cognitive Training | 6.14 | 8.24 | 7.55 | 106.06 | 108.12 | 106.98 |
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Change in Total Fluid Cognitive Score
"Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured fluid cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment." (NCT03272711)
Timeframe: Randomization (0 weeks), 4 weeks
Intervention | score on a scale (Mean) |
---|
| Change in Total Fluid Cognitive Score | Week 4 Total Fluid Cogntive Score |
---|
Placebo Plus Cognitive Training | 3.71 | 105.85 |
,Vortioxetine Plus Cognitive Training | 6.14 | 106.06 |
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Participant Function
"Participant function assessed using the UCSD Performance-Based Skills Assessment (UPSA).~A validated test that required participants to demonstrate their competence to perform everyday functioning tasks in domains such as comprehension, planning, finances, transportation and communication. A higher scores indicates a better outcome. Scores can range from a minimum of 0 to a maximum of 100." (NCT03272711)
Timeframe: Randomization (0 weeks), 26 weeks
Intervention | score on a scale (Mean) |
---|
| Change in UPSA Score | Total UPSA Score at Week 26 |
---|
Placebo Plus Cognitive Training | 1.66 | 82.44 |
,Vortioxetine Plus Cognitive Training | 2.91 | 84.50 |
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AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Unchanged Lu AA21004
(NCT03437564)
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Intervention | h*ng/mL (Mean) |
---|
Vortioxetine One 20 mg Tablet | 463.9 |
Vortioxetine Two 10 mg Tablets | 477.6 |
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AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004
(NCT03437564)
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Intervention | hour*nanogram per milliliter (h*ng/mL) (Mean) |
---|
Vortioxetine One 20 mg Tablet | 299.3 |
Vortioxetine Two 10 mg Tablets | 301.1 |
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Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004
(NCT03437564)
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Intervention | ng/mL (Mean) |
---|
Vortioxetine One 20 mg Tablet | 8.744 |
Vortioxetine Two 10 mg Tablets | 8.976 |
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MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration of Unchanged Lu AA21004
(NCT03437564)
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Intervention | Hours (Mean) |
---|
Vortioxetine One 20 mg Tablet | 30.12 |
Vortioxetine Two 10 mg Tablets | 30.12 |
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λz: Apparent Elimination Rate Constant of Unchanged Lu AA21004
(NCT03437564)
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Intervention | 1/Hours (Mean) |
---|
Vortioxetine One 20 mg Tablet | 0.01608 |
Vortioxetine Two 10 mg Tablets | 0.01599 |
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Tmax: Time to Reach Cmax (Observed Value) of Unchanged Lu AA21004
(NCT03437564)
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Intervention | Hours (Median) |
---|
Vortioxetine One 20 mg Tablet | 6.000 |
Vortioxetine Two 10 mg Tablets | 6.000 |
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MRT∞, ev: Mean Residence Time 0 to Infinity of Unchanged Lu AA21004
(NCT03437564)
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Intervention | Hours (Mean) |
---|
Vortioxetine One 20 mg Tablet | 67.27 |
Vortioxetine Two 10 mg Tablets | 68.84 |
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Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
(NCT03437564)
Timeframe: Up to Day 25
Intervention | Participants (Count of Participants) |
---|
Vortioxetine One 20 mg Tablet | 1 |
Vortioxetine Two 10 mg Tablets | 0 |
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T1/2z: Apparent Elimination Half-Life of Unchanged Lu AA21004
(NCT03437564)
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Intervention | Hours (Mean) |
---|
Vortioxetine One 20 mg Tablet | 45.36 |
Vortioxetine Two 10 mg Tablets | 46.44 |
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