Major Depressive Disorder
Conditions
Keywords
Depression, Depressive Disorder, Mood Disorder, Mental Disorder, Melancholia, Involutional, Paraphrenia, Involutional, Drug Therapy
Brief summary
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.
Detailed description
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine. The study enrolled 560 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 1 mg * Vortioxetine 5 mg * Vortioxetine 10 mg * Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient. All participants were asked to take one capsule at the same time each day throughout the study. This multi-centre trial was conducted in Europe, Asia, Australia, and South Africa. The overall time to participate in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
Interventions
DRUGVortioxetine
Encapsulated immediate-release vortioxetine tablets
DRUGPlacebo
Vortioxetine placebo-matching capsules
Sponsors
H. Lundbeck A/S
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. * The reported duration of the current major depressive episode is at least 3 months. * Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26. * A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.
Exclusion criteria
* Has 1 or more the following: * Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR. * Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. * Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline). * Presence or history of a clinically significant neurological disorder (including epilepsy). * Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc). * Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months. * Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study. * Has a clinically significant unstable illness. * Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors. * Has received electroconvulsive therapy within 6 months prior to Screening. * Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level \> 1.5 times the upper limit of normal. * Has a serum creatinine of \> 1.5 × upper limit of normal. * Has a previous history of cancer that had been in remission for less than 5 years. * Has thyroid stimulating hormone value outside the normal range. * Has an abnormal electrocardiogram.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale-Global Improvement at Week 8 | Baseline to 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. |
| Percentage of Responders in HAM-D24 Total Score at Week 8 | Baseline and 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. |
| Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20 | Baseline to 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. 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. |
| Percentage of Participants in MADRS Remission at Week 8 | 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. |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Baseline and Weeks 1, 2, 4 and 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. 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. |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Baseline and Weeks 1, 2 and 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis. |
| Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Baseline and Weeks 1, 2, 4 and 6 | 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. |
| Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Baseline and Weeks 1, 2, 4 and 6 | 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. |
| Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Baseline and Weeks 1, 2, 4 and 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 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. |
| Percentage of Participants in MADRS Remission at Other Weeks Assessed | Weeks 1, 2, 4 and 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. |
| Percentage of Participants With a Sustained Response in HAM-D24 Total Score | From Baseline through Week 8 | 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. |
| Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Baseline and Weeks 1, 2, 4, 6, and 8 | 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. |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | Baseline to 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. |
| Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Baseline and Weeks 1, 2, 4, 6, and 8 | 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. |
| Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Baseline and Weeks 1, 4, and 8 | 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 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Baseline and Weeks 2, 4 and 8 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). 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. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Baseline and Weeks 2, 4 and 8 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). 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. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Baseline and Weeks 2, 4 and 8 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). 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. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Baseline and Weeks 2, 4 and 8 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). 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. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Baseline and Weeks 2, 4 and 8 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). 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. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Baseline and Weeks 2 and 4 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). 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. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Baseline and Weeks 2, 4 and 8 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). 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. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Baseline and Weeks 2, 4 and 8 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). 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. |
| Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline and Week 8 | 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. |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Baseline and Weeks 1, 2, 4, 6, and 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. 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. |
Countries
Australia, Czechia, France, Germany, Latvia, Lithuania, Malaysia, Netherlands, Poland, Russia, South Africa, South Korea, Taiwan, Ukraine, United Kingdom
Participant flow
Recruitment details
Participants took part in the study at 51 investigative sites in Australia, Croatia, France, Germany, Latvia, Lithuania, Malaysia, Netherlands, Poland, Republic of Korea, Russia, South Africa, Taiwan, and Ukraine from 14 August 2008 to 13 August 2009.
Pre-assignment details
Participants with a diagnosis of major depressive disorder were randomized equally in 1 of 4 treatment groups, once daily placebo, 1 mg, 5 mg, or 10 mg vortioxetine.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. | 140 |
| Vortioxetine 1 mg Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks. | 140 |
| Vortioxetine 5 mg Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks. | 140 |
| Vortioxetine 10 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks. | 140 |
| Total | 560 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 1 | 5 |
| Overall Study | Excluded medication | 1 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 8 | 4 | 2 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 1 |
| Overall Study | Noncompliance | 0 | 0 | 1 | 0 |
| Overall Study | Protocol deviations | 1 | 2 | 1 | 1 |
| Overall Study | Voluntary Withdrawal | 1 | 3 | 5 | 7 |
Baseline characteristics
| Characteristic | Total | Placebo | Vortioxetine 1 mg | Vortioxetine 5 mg | Vortioxetine 10 mg |
|---|---|---|---|---|---|
| 24-item Hamilton Depression Scale total score | 32.6 scores on a scale STANDARD_DEVIATION 4.84 | 32.7 scores on a scale STANDARD_DEVIATION 4.4 | 32.5 scores on a scale STANDARD_DEVIATION 5.13 | 32.1 scores on a scale STANDARD_DEVIATION 5.04 | 33.1 scores on a scale STANDARD_DEVIATION 4.77 |
| Age Continuous | 46.4 years STANDARD_DEVIATION 12.08 | 46.4 years STANDARD_DEVIATION 12.26 | 45.4 years STANDARD_DEVIATION 11.89 | 47.3 years STANDARD_DEVIATION 11.95 | 46.4 years STANDARD_DEVIATION 12.27 |
| Age, Customized ≤55 years | 422 participants | 103 participants | 110 participants | 102 participants | 107 participants |
| Age, Customized >55 years | 138 participants | 37 participants | 30 participants | 38 participants | 33 participants |
| Alcohol Consumption 2-to-6 times/week | 35 participants | 5 participants | 11 participants | 7 participants | 12 participants |
| Alcohol Consumption Daily | 30 participants | 9 participants | 5 participants | 9 participants | 7 participants |
| Alcohol Consumption Never | 214 participants | 53 participants | 51 participants | 56 participants | 54 participants |
| Alcohol Consumption Once monthly or less often | 227 participants | 57 participants | 60 participants | 59 participants | 51 participants |
| Alcohol Consumption Once per week | 54 participants | 16 participants | 13 participants | 9 participants | 16 participants |
| Body Mass Index (BMI) | 26.36 kg/m^2 STANDARD_DEVIATION 4.917 | 26.36 kg/m^2 STANDARD_DEVIATION 4.615 | 26.53 kg/m^2 STANDARD_DEVIATION 5.38 | 26.41 kg/m^2 STANDARD_DEVIATION 5.065 | 26.16 kg/m^2 STANDARD_DEVIATION 4.612 |
| Clinical Global Impression - Severity scale score | 4.8 scores on a scale STANDARD_DEVIATION 0.76 | 4.8 scores on a scale STANDARD_DEVIATION 0.8 | 4.7 scores on a scale STANDARD_DEVIATION 0.73 | 4.8 scores on a scale STANDARD_DEVIATION 0.73 | 4.9 scores on a scale STANDARD_DEVIATION 0.76 |
| Hamilton Anxiety Scale total score | 20.0 scores on a scale STANDARD_DEVIATION 6.93 | 19.7 scores on a scale STANDARD_DEVIATION 7.07 | 20.0 scores on a scale STANDARD_DEVIATION 6.41 | 19.4 scores on a scale STANDARD_DEVIATION 6.77 | 21.1 scores on a scale STANDARD_DEVIATION 7.39 |
| Height | 168.63 cm STANDARD_DEVIATION 9.129 | 168.70 cm STANDARD_DEVIATION 8.907 | 168.56 cm STANDARD_DEVIATION 8.264 | 168.56 cm STANDARD_DEVIATION 9.126 | 168.70 cm STANDARD_DEVIATION 10.209 |
| Hospital Anxiety and Depression - Depression subscale | 13.7 scores on a scale STANDARD_DEVIATION 3.99 | 13.7 scores on a scale STANDARD_DEVIATION 4.33 | 13.8 scores on a scale STANDARD_DEVIATION 3.88 | 13.4 scores on a scale STANDARD_DEVIATION 4.02 | 13.8 scores on a scale STANDARD_DEVIATION 3.71 |
| Hospital Anxiety and Depression (HAD) - Anxiety subscale | 11.4 scores on a scale STANDARD_DEVIATION 3.95 | 11.2 scores on a scale STANDARD_DEVIATION 3.99 | 11.2 scores on a scale STANDARD_DEVIATION 3.83 | 11.6 scores on a scale STANDARD_DEVIATION 4.02 | 11.7 scores on a scale STANDARD_DEVIATION 3.97 |
| Montgomery Åsberg Depression Rating Scale (MADRS) total score | 30.8 scores on a scale STANDARD_DEVIATION 3.19 | 30.6 scores on a scale STANDARD_DEVIATION 2.89 | 30.4 scores on a scale STANDARD_DEVIATION 3.01 | 30.6 scores on a scale STANDARD_DEVIATION 2.83 | 31.6 scores on a scale STANDARD_DEVIATION 3.83 |
| Race/Ethnicity, Customized Asian | 62 participants | 14 participants | 8 participants | 17 participants | 23 participants |
| Race/Ethnicity, Customized Black | 10 participants | 5 participants | 1 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Caucasian | 483 participants | 120 participants | 129 participants | 120 participants | 114 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 participants | 3 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Non-Hispanic/Non-Latino | 556 participants | 137 participants | 140 participants | 140 participants | 139 participants |
| Race/Ethnicity, Customized Other | 5 participants | 1 participants | 2 participants | 1 participants | 1 participants |
| Region of Enrollment Australia | 4 participants | 0 participants | 3 participants | 0 participants | 1 participants |
| Region of Enrollment Croatia | 13 participants | 2 participants | 5 participants | 5 participants | 1 participants |
| Region of Enrollment France | 13 participants | 5 participants | 2 participants | 1 participants | 5 participants |
| Region of Enrollment Germany | 233 participants | 63 participants | 50 participants | 64 participants | 56 participants |
| Region of Enrollment Latvia | 27 participants | 5 participants | 8 participants | 9 participants | 5 participants |
| Region of Enrollment Lithuania | 13 participants | 4 participants | 4 participants | 2 participants | 3 participants |
| Region of Enrollment Malaysia | 22 participants | 7 participants | 3 participants | 6 participants | 6 participants |
| Region of Enrollment Netherlands | 7 participants | 0 participants | 3 participants | 3 participants | 1 participants |
| Region of Enrollment Poland | 62 participants | 20 participants | 16 participants | 15 participants | 11 participants |
| Region of Enrollment Republic of Korea | 35 participants | 7 participants | 5 participants | 9 participants | 14 participants |
| Region of Enrollment Russia | 61 participants | 12 participants | 20 participants | 9 participants | 20 participants |
| Region of Enrollment South Africa | 19 participants | 5 participants | 6 participants | 5 participants | 3 participants |
| Region of Enrollment Taiwan | 4 participants | 0 participants | 0 participants | 1 participants | 3 participants |
| Region of Enrollment Ukraine | 47 participants | 10 participants | 15 participants | 11 participants | 11 participants |
| Sex: Female, Male Female | 351 Participants | 86 Participants | 93 Participants | 87 Participants | 85 Participants |
| Sex: Female, Male Male | 209 Participants | 54 Participants | 47 Participants | 53 Participants | 55 Participants |
| Smoking Classification Current smoker | 162 participants | 34 participants | 54 participants | 33 participants | 41 participants |
| Smoking Classification Ex-smoker | 69 participants | 18 participants | 12 participants | 19 participants | 20 participants |
| Smoking Classification Never smoked | 329 participants | 88 participants | 74 participants | 88 participants | 79 participants |
| Weight | 75.20 kg STANDARD_DEVIATION 16.099 | 75.18 kg STANDARD_DEVIATION 14.924 | 75.63 kg STANDARD_DEVIATION 17.276 | 75.41 kg STANDARD_DEVIATION 17.022 | 74.58 kg STANDARD_DEVIATION 15.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 140 | 36 / 140 | 56 / 140 | 39 / 139 |
| serious Total, serious adverse events | 2 / 140 | 1 / 140 | 1 / 140 | 2 / 139 |
Outcome results
Primary
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.
Time frame: Baseline to Week 8
Population: The full analysis set (FAS) included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 | -11.30 scores on a scale | Standard Error 0.738 |
| Vortioxetine 1 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 | -14.82 scores on a scale | Standard Error 0.745 |
| Vortioxetine 5 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 | -15.42 scores on a scale | Standard Error 0.743 |
| Vortioxetine 10 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 | -16.23 scores on a scale | Standard Error 0.755 |
Comparison: All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.p-value: <0.00195% CI: [-6.99, -2.86]Mixed model for repeated measurements
p-value: <0.00195% CI: [-6.17, -2.08]Mixed model for repeated measurements
p-value: <0.00195% CI: [-5.57, -1.47]Mixed model for repeated measurements
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). 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.
Time frame: Baseline and Weeks 2, 4 and 8
Population: Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 2.99 scores on a scale | Standard Error 1.63 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 7.17 scores on a scale | Standard Error 1.92 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 4.45 scores on a scale | Standard Error 1.738 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 5.06 scores on a scale | Standard Error 1.624 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 11.99 scores on a scale | Standard Error 1.92 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 5.33 scores on a scale | Standard Error 1.752 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 7.75 scores on a scale | Standard Error 1.744 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 4.52 scores on a scale | Standard Error 1.644 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 9.63 scores on a scale | Standard Error 1.928 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 7.22 scores on a scale | Standard Error 1.644 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 12.89 scores on a scale | Standard Error 1.97 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 10.66 scores on a scale | Standard Error 1.778 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). 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.
Time frame: Baseline and Weeks 2, 4 and 8
Population: Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 2.83 scores on a scale | Standard Error 1.048 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 121) | 8.68 scores on a scale | Standard Error 1.392 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 6.51 scores on a scale | Standard Error 1.235 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 5.54 scores on a scale | Standard Error 1.044 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 121) | 12.46 scores on a scale | Standard Error 1.395 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 8.98 scores on a scale | Standard Error 1.245 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 9.96 scores on a scale | Standard Error 1.238 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 5.64 scores on a scale | Standard Error 1.054 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 121) | 13.67 scores on a scale | Standard Error 1.396 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 5.47 scores on a scale | Standard Error 1.056 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 121) | 13.87 scores on a scale | Standard Error 1.429 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 10.99 scores on a scale | Standard Error 1.263 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). 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.
Time frame: Baseline and Weeks 2, 4 and 8
Population: Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 6.98 scores on a scale | Standard Error 1.199 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 16.28 scores on a scale | Standard Error 1.625 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 4 (n= 135, 132, 135, 128) | 13.06 scores on a scale | Standard Error 1.418 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 10.62 scores on a scale | Standard Error 1.192 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 23.61 scores on a scale | Standard Error 1.628 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 4 (n= 135, 132, 135, 128) | 16.78 scores on a scale | Standard Error 1.429 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 4 (n= 135, 132, 135, 128) | 16.56 scores on a scale | Standard Error 1.421 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 9.56 scores on a scale | Standard Error 1.205 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 22.24 scores on a scale | Standard Error 1.631 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 10.26 scores on a scale | Standard Error 1.207 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 24.89 scores on a scale | Standard Error 1.667 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed | Week 4 (n= 135, 132, 135, 128) | 16.38 scores on a scale | Standard Error 1.451 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). 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.
Time frame: Baseline and Weeks 2, 4 and 8
Population: Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 2 (n=138,139,136,136) | 2.24 scores on a scale | Standard Error 1.279 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 8 (n=129,129,128,122) | 8.77 scores on a scale | Standard Error 1.407 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 4 (n=135,132,135,128) | 5.10 scores on a scale | Standard Error 1.354 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 2 (n=138,139,136,136) | 5.39 scores on a scale | Standard Error 1.273 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 8 (n=129,129,128,122) | 9.59 scores on a scale | Standard Error 1.408 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 4 (n=135,132,135,128) | 7.77 scores on a scale | Standard Error 1.364 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 4 (n=135,132,135,128) | 9.35 scores on a scale | Standard Error 1.356 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 2 (n=138,139,136,136) | 7.55 scores on a scale | Standard Error 1.285 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 8 (n=129,129,128,122) | 12.31 scores on a scale | Standard Error 1.411 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 2 (n=138,139,136,136) | 3.34 scores on a scale | Standard Error 1.289 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 8 (n=129,129,128,122) | 11.28 scores on a scale | Standard Error 1.441 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed | Week 4 (n=135,132,135,128) | 6.92 scores on a scale | Standard Error 1.385 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). 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.
Time frame: Baseline and Weeks 2, 4 and 8
Population: Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 6.84 scores on a scale | Standard Error 1.57 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 15.96 scores on a scale | Standard Error 1.941 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 12.05 scores on a scale | Standard Error 1.755 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 8.78 scores on a scale | Standard Error 1.563 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 23.06 scores on a scale | Standard Error 1.946 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 17.01 scores on a scale | Standard Error 1.772 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 18.08 scores on a scale | Standard Error 1.758 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 10.87 scores on a scale | Standard Error 1.579 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 22.89 scores on a scale | Standard Error 1.947 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 9.93 scores on a scale | Standard Error 1.581 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 24.71 scores on a scale | Standard Error 1.99 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 14.58 scores on a scale | Standard Error 1.797 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). 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.
Time frame: Baseline and Weeks 2, 4 and 8
Population: Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 0.74 scores on a scale | Standard Error 1.511 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 8.46 scores on a scale | Standard Error 1.83 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 4.53 scores on a scale | Standard Error 1.706 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 6.09 scores on a scale | Standard Error 1.505 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 14.09 scores on a scale | Standard Error 1.833 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 10.62 scores on a scale | Standard Error 1.721 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 12.97 scores on a scale | Standard Error 1.709 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 7.38 scores on a scale | Standard Error 1.52 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 15.64 scores on a scale | Standard Error 1.835 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 5.00 scores on a scale | Standard Error 1.525 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 15.76 scores on a scale | Standard Error 1.878 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 8.28 scores on a scale | Standard Error 1.748 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). 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.
Time frame: Baseline and Weeks 2 and 4
Population: Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 6.38 scores on a scale | Standard Error 1.479 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 15.60 scores on a scale | Standard Error 1.989 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 12.34 scores on a scale | Standard Error 1.76 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 9.71 scores on a scale | Standard Error 1.473 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 21.71 scores on a scale | Standard Error 1.991 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 15.71 scores on a scale | Standard Error 1.775 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 18.57 scores on a scale | Standard Error 1.762 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 12.02 scores on a scale | Standard Error 1.486 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 21.87 scores on a scale | Standard Error 1.993 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 10.03 scores on a scale | Standard Error 1.491 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 24.94 scores on a scale | Standard Error 2.04 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 15.84 scores on a scale | Standard Error 1.804 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). 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.
Time frame: Baseline and Weeks 2, 4 and 8
Population: Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 5.97 scores on a scale | Standard Error 1.199 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 16.14 scores on a scale | Standard Error 1.748 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 12.06 scores on a scale | Standard Error 1.523 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 10.39 scores on a scale | Standard Error 1.193 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 22.34 scores on a scale | Standard Error 1.752 |
| Vortioxetine 1 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 16.69 scores on a scale | Standard Error 1.536 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 16.04 scores on a scale | Standard Error 1.526 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 8.83 scores on a scale | Standard Error 1.205 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 21.21 scores on a scale | Standard Error 1.753 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 2 (n=138, 139, 136, 136) | 8.03 scores on a scale | Standard Error 1.208 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 8 (n=129, 129, 128, 122) | 24.17 scores on a scale | Standard Error 1.793 |
| Vortioxetine 10 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed | Week 4 (n=135, 132, 135, 128) | 16.07 scores on a scale | Standard Error 1.56 |
Secondary
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.
Time frame: Baseline and Weeks 1, 2, 4, 6, and 8
Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 6 (n=134, 130, 129, 126) | -0.96 scores on a scale | Standard Error 0.092 |
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 2 (n=138, 138, 135, 135) | -0.46 scores on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 8 (n=128, 124, 129, 122) | -1.12 scores on a scale | Standard Error 0.101 |
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 4 (n=135, 133, 135, 127) | -0.75 scores on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 1 (n=139, 137, 138, 138) | -0.24 scores on a scale | Standard Error 0.044 |
| Vortioxetine 1 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 4 (n=135, 133, 135, 127) | -1.07 scores on a scale | Standard Error 0.081 |
| Vortioxetine 1 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 6 (n=134, 130, 129, 126) | -1.41 scores on a scale | Standard Error 0.093 |
| Vortioxetine 1 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 8 (n=128, 124, 129, 122) | -1.50 scores on a scale | Standard Error 0.102 |
| Vortioxetine 1 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 2 (n=138, 138, 135, 135) | -0.58 scores on a scale | Standard Error 0.062 |
| Vortioxetine 1 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 1 (n=139, 137, 138, 138) | -0.20 scores on a scale | Standard Error 0.045 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 4 (n=135, 133, 135, 127) | -1.10 scores on a scale | Standard Error 0.081 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 1 (n=139, 137, 138, 138) | -0.22 scores on a scale | Standard Error 0.044 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 2 (n=138, 138, 135, 135) | -0.61 scores on a scale | Standard Error 0.062 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 6 (n=134, 130, 129, 126) | -1.38 scores on a scale | Standard Error 0.093 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 8 (n=128, 124, 129, 122) | -1.63 scores on a scale | Standard Error 0.101 |
| Vortioxetine 10 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 6 (n=134, 130, 129, 126) | -1.55 scores on a scale | Standard Error 0.094 |
| Vortioxetine 10 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 2 (n=138, 138, 135, 135) | -0.60 scores on a scale | Standard Error 0.062 |
| Vortioxetine 10 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 1 (n=139, 137, 138, 138) | -0.24 scores on a scale | Standard Error 0.044 |
| Vortioxetine 10 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 4 (n=135, 133, 135, 127) | -1.06 scores on a scale | Standard Error 0.082 |
| Vortioxetine 10 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 8 (n=128, 124, 129, 122) | -1.74 scores on a scale | Standard Error 0.103 |
Secondary
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.
Time frame: Baseline and Weeks 1, 2, 4 and 6
Population: Full analysis set patients with a HAM-A Baseline score ≥20 and with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 1 (n=66, 70, 62, 75) | -3.79 scores on a scale | Standard Error 0.473 |
| Placebo | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 2 (n=65, 70, 59, 72) | -5.76 scores on a scale | Standard Error 0.637 |
| Placebo | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 4 (n=64, 68, 60, 69) | -8.56 scores on a scale | Standard Error 0.874 |
| Placebo | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 6 (n=64, 67, 57, 68) | -10.25 scores on a scale | Standard Error 0.958 |
| Vortioxetine 1 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 2 (n=65, 70, 59, 72) | -7.21 scores on a scale | Standard Error 0.618 |
| Vortioxetine 1 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 4 (n=64, 68, 60, 69) | -11.41 scores on a scale | Standard Error 0.85 |
| Vortioxetine 1 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 6 (n=64, 67, 57, 68) | -13.68 scores on a scale | Standard Error 0.932 |
| Vortioxetine 1 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 1 (n=66, 70, 62, 75) | -2.94 scores on a scale | Standard Error 0.463 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 4 (n=64, 68, 60, 69) | -10.20 scores on a scale | Standard Error 0.91 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 2 (n=65, 70, 59, 72) | -6.58 scores on a scale | Standard Error 0.667 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 6 (n=64, 67, 57, 68) | -13.23 scores on a scale | Standard Error 1.002 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 1 (n=66, 70, 62, 75) | -3.55 scores on a scale | Standard Error 0.491 |
| Vortioxetine 10 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 6 (n=64, 67, 57, 68) | -15.10 scores on a scale | Standard Error 0.923 |
| Vortioxetine 10 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 2 (n=65, 70, 59, 72) | -7.74 scores on a scale | Standard Error 0.607 |
| Vortioxetine 10 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 1 (n=66, 70, 62, 75) | -3.19 scores on a scale | Standard Error 0.447 |
| Vortioxetine 10 mg | Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 | Week 4 (n=64, 68, 60, 69) | -12.06 scores on a scale | Standard Error 0.841 |
Secondary
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.
Time frame: Baseline to Week 8
Population: Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20 | -11.02 scores on a scale | Standard Error 1.017 |
| Vortioxetine 1 mg | Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20 | -15.16 scores on a scale | Standard Error 0.991 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20 | -15.50 scores on a scale | Standard Error 1.063 |
| Vortioxetine 10 mg | Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20 | -15.61 scores on a scale | Standard Error 0.984 |
p-value: 0.00195% CI: [-7.34, -1.84]Mixed model for repeated measurements
p-value: 0.00295% CI: [-7.32, -1.62]Mixed model for repeated measurements
p-value: 0.00495% CI: [-6.9, -1.37]Mixed model for repeated measurements
Secondary
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.
Time frame: Baseline and Weeks 1, 2, 4, 6, and 8
Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 6 (n=134, 130, 129, 126) | -5.44 scores on a scale | Standard Error 0.471 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 2 (n=138, 138, 135, 135) | -3.06 scores on a scale | Standard Error 0.343 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 8 (n=128, 124, 129, 122) | -5.98 scores on a scale | Standard Error 0.498 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 4 (n=135, 133, 135, 127) | -4.54 scores on a scale | Standard Error 0.416 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 1 (n=139, 137, 138, 138) | -1.58 scores on a scale | Standard Error 0.26 |
| Vortioxetine 1 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 4 (n=135, 133, 135, 127) | -5.95 scores on a scale | Standard Error 0.418 |
| Vortioxetine 1 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 6 (n=134, 130, 129, 126) | -7.29 scores on a scale | Standard Error 0.475 |
| Vortioxetine 1 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 8 (n=128, 124, 129, 122) | -8.08 scores on a scale | Standard Error 0.503 |
| Vortioxetine 1 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 2 (n=138, 138, 135, 135) | -3.72 scores on a scale | Standard Error 0.343 |
| Vortioxetine 1 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 1 (n=139, 137, 138, 138) | -1.27 scores on a scale | Standard Error 0.261 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 4 (n=135, 133, 135, 127) | -5.60 scores on a scale | Standard Error 0.418 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 1 (n=139, 137, 138, 138) | -1.41 scores on a scale | Standard Error 0.261 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 2 (n=138, 138, 135, 135) | -3.09 scores on a scale | Standard Error 0.346 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 6 (n=134, 130, 129, 126) | -7.21 scores on a scale | Standard Error 0.476 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 8 (n=128, 124, 129, 122) | -8.11 scores on a scale | Standard Error 0.501 |
| Vortioxetine 10 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 6 (n=134, 130, 129, 126) | -8.33 scores on a scale | Standard Error 0.483 |
| Vortioxetine 10 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 2 (n=138, 138, 135, 135) | -3.77 scores on a scale | Standard Error 0.347 |
| Vortioxetine 10 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 1 (n=139, 137, 138, 138) | -1.56 scores on a scale | Standard Error 0.261 |
| Vortioxetine 10 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 4 (n=135, 133, 135, 127) | -6.11 scores on a scale | Standard Error 0.425 |
| Vortioxetine 10 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed | Week 8 (n=128, 124, 129, 122) | -8.86 scores on a scale | Standard Error 0.511 |
Secondary
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
Time frame: Baseline and Weeks 1, 4, and 8
Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 1 (n=139, 137, 138, 137) | -0.46 scores on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 4 (n=137, 138, 135, 134) | -1.95 scores on a scale | Standard Error 0.277 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 8 (n=129, 129, 127, 122) | -2.55 scores on a scale | Standard Error 0.315 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 1 (n=139, 137, 138, 137) | -0.32 scores on a scale | Standard Error 0.217 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 4 (n=137, 138, 135, 134) | -2.32 scores on a scale | Standard Error 0.348 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 8 (n=129, 129, 127, 122) | -3.19 scores on a scale | Standard Error 0.392 |
| Vortioxetine 1 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 8 (n=129, 129, 127, 122) | -4.67 scores on a scale | Standard Error 0.393 |
| Vortioxetine 1 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 1 (n=139, 137, 138, 137) | -0.90 scores on a scale | Standard Error 0.217 |
| Vortioxetine 1 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 1 (n=139, 137, 138, 137) | -1.14 scores on a scale | Standard Error 0.19 |
| Vortioxetine 1 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 8 (n=129, 129, 127, 122) | -3.79 scores on a scale | Standard Error 0.315 |
| Vortioxetine 1 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 4 (n=137, 138, 135, 134) | -2.83 scores on a scale | Standard Error 0.276 |
| Vortioxetine 1 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 4 (n=137, 138, 135, 134) | -3.45 scores on a scale | Standard Error 0.347 |
| Vortioxetine 5 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 4 (n=137, 138, 135, 134) | -2.81 scores on a scale | Standard Error 0.278 |
| Vortioxetine 5 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 8 (n=129, 129, 127, 122) | -3.70 scores on a scale | Standard Error 0.317 |
| Vortioxetine 5 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 1 (n=139, 137, 138, 137) | -0.74 scores on a scale | Standard Error 0.216 |
| Vortioxetine 5 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 8 (n=129, 129, 127, 122) | -5.02 scores on a scale | Standard Error 0.396 |
| Vortioxetine 5 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 4 (n=137, 138, 135, 134) | -3.32 scores on a scale | Standard Error 0.35 |
| Vortioxetine 5 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 1 (n=139, 137, 138, 137) | -0.87 scores on a scale | Standard Error 0.189 |
| Vortioxetine 10 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 4 (n=137, 138, 135, 134) | -3.80 scores on a scale | Standard Error 0.352 |
| Vortioxetine 10 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 8 (n=129, 129, 127, 122) | -5.49 scores on a scale | Standard Error 0.401 |
| Vortioxetine 10 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 4 (n=137, 138, 135, 134) | -2.80 scores on a scale | Standard Error 0.279 |
| Vortioxetine 10 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Depression Scale at Week 1 (n=139, 137, 138, 137) | -0.92 scores on a scale | Standard Error 0.218 |
| Vortioxetine 10 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 1 (n=139, 137, 138, 137) | -0.91 scores on a scale | Standard Error 0.19 |
| Vortioxetine 10 mg | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed | Anxiety Scale at Week 8 (n=129, 129, 127, 122) | -4.38 scores on a scale | Standard Error 0.321 |
Secondary
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.
Time frame: Baseline and Weeks 1, 2, 4, 6, and 8
Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 4 (n=135, 133, 135, 127) | -7.85 scores on a scale | Standard Error 0.619 |
| Placebo | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 1 (n=139, 137, 138, 138) | -2.90 scores on a scale | Standard Error 0.324 |
| Placebo | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 6 (n=134, 130, 129, 126) | -9.72 scores on a scale | Standard Error 0.675 |
| Placebo | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 2 (n=138, 138, 135, 135) | -4.92 scores on a scale | Standard Error 0.463 |
| Placebo | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 8 (n=128, 124, 129, 122) | -10.91 scores on a scale | Standard Error 0.708 |
| Vortioxetine 1 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 4 (n=135, 133, 135, 127) | -10.79 scores on a scale | Standard Error 0.622 |
| Vortioxetine 1 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 2 (n=138, 138, 135, 135) | -6.65 scores on a scale | Standard Error 0.463 |
| Vortioxetine 1 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 6 (n=134, 130, 129, 126) | -13.16 scores on a scale | Standard Error 0.68 |
| Vortioxetine 1 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 1 (n=139, 137, 138, 138) | -2.55 scores on a scale | Standard Error 0.326 |
| Vortioxetine 1 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 8 (n=128, 124, 129, 122) | -14.89 scores on a scale | Standard Error 0.715 |
| Vortioxetine 5 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 8 (n=128, 124, 129, 122) | -15.09 scores on a scale | Standard Error 0.712 |
| Vortioxetine 5 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 1 (n=139, 137, 138, 138) | -2.66 scores on a scale | Standard Error 0.324 |
| Vortioxetine 5 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 2 (n=138, 138, 135, 135) | -6.40 scores on a scale | Standard Error 0.467 |
| Vortioxetine 5 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 4 (n=135, 133, 135, 127) | -10.30 scores on a scale | Standard Error 0.622 |
| Vortioxetine 5 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 6 (n=134, 130, 129, 126) | -13.10 scores on a scale | Standard Error 0.68 |
| Vortioxetine 10 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 8 (n=128, 124, 129, 122) | -15.65 scores on a scale | Standard Error 0.728 |
| Vortioxetine 10 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 6 (n=134, 130, 129, 126) | -14.19 scores on a scale | Standard Error 0.694 |
| Vortioxetine 10 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 2 (n=138, 138, 135, 135) | -6.51 scores on a scale | Standard Error 0.472 |
| Vortioxetine 10 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 1 (n=139, 137, 138, 138) | -2.57 scores on a scale | Standard Error 0.328 |
| Vortioxetine 10 mg | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week | Week 4 (n=135, 133, 135, 127) | -10.89 scores on a scale | Standard Error 0.635 |
Secondary
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.
Time frame: Baseline and Weeks 1, 2 and 6
Population: Full analysis set with available SDS Total Score data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 1 (n=104, 101, 105, 97) | -1.22 scores on a scale | Standard Error 0.392 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 6 (n=99, 97, 97, 88) | -5.95 scores on a scale | Standard Error 0.672 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 2 (n=102, 101, 100, 96) | -2.53 scores on a scale | Standard Error 0.507 |
| Vortioxetine 1 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 1 (n=104, 101, 105, 97) | -1.13 scores on a scale | Standard Error 0.399 |
| Vortioxetine 1 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 6 (n=99, 97, 97, 88) | -5.69 scores on a scale | Standard Error 0.681 |
| Vortioxetine 1 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 2 (n=102, 101, 100, 96) | -3.44 scores on a scale | Standard Error 0.511 |
| Vortioxetine 5 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 2 (n=102, 101, 100, 96) | -4.14 scores on a scale | Standard Error 0.512 |
| Vortioxetine 5 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 1 (n=104, 101, 105, 97) | -1.78 scores on a scale | Standard Error 0.393 |
| Vortioxetine 5 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 6 (n=99, 97, 97, 88) | -6.92 scores on a scale | Standard Error 0.678 |
| Vortioxetine 10 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 1 (n=104, 101, 105, 97) | -1.43 scores on a scale | Standard Error 0.403 |
| Vortioxetine 10 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 6 (n=99, 97, 97, 88) | -8.27 scores on a scale | Standard Error 0.707 |
| Vortioxetine 10 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 2 (n=102, 101, 100, 96) | -3.40 scores on a scale | Standard Error 0.521 |
Secondary
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.
Time frame: Baseline to Week 8
Population: Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | -6.54 scores on a scale | Standard Error 0.716 |
| Vortioxetine 1 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | -6.58 scores on a scale | Standard Error 0.729 |
| Vortioxetine 5 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | -7.65 scores on a scale | Standard Error 0.713 |
| Vortioxetine 10 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | -8.08 scores on a scale | Standard Error 0.756 |
p-value: 0.13595% CI: [-3.56, 0.48]Mixed model repeated measurements
p-value: 0.26395% CI: [-3.07, 0.84]Mixed model repeated measurements
p-value: 0.96395% CI: [-2.03, 1.94]Mixed model repeated measurements
Secondary
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.
Time frame: Baseline and Weeks 1, 2, 4 and 6
Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | -3.47 scores on a scale | Standard Error 0.321 |
| Placebo | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 2 (n=138, 138, 135, 135) | -5.66 scores on a scale | Standard Error 0.485 |
| Placebo | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 4 (n=135, 133, 135, 127) | -8.42 scores on a scale | Standard Error 0.634 |
| Placebo | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 6 (n=134, 130, 129, 126) | -10.23 scores on a scale | Standard Error 0.69 |
| Vortioxetine 1 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 2 (n=138, 138, 135, 135) | -7.27 scores on a scale | Standard Error 0.485 |
| Vortioxetine 1 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 4 (n=135, 133, 135, 127) | -11.09 scores on a scale | Standard Error 0.637 |
| Vortioxetine 1 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 6 (n=134, 130, 129, 126) | -13.35 scores on a scale | Standard Error 0.695 |
| Vortioxetine 1 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | -2.81 scores on a scale | Standard Error 0.323 |
| Vortioxetine 5 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 4 (n=135, 133, 135, 127) | -11.00 scores on a scale | Standard Error 0.639 |
| Vortioxetine 5 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 2 (n=138, 138, 135, 135) | -7.27 scores on a scale | Standard Error 0.49 |
| Vortioxetine 5 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 6 (n=134, 130, 129, 126) | -13.67 scores on a scale | Standard Error 0.697 |
| Vortioxetine 5 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | -3.20 scores on a scale | Standard Error 0.322 |
| Vortioxetine 10 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 6 (n=134, 130, 129, 126) | -15.22 scores on a scale | Standard Error 0.705 |
| Vortioxetine 10 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 2 (n=138, 138, 135, 135) | -7.42 scores on a scale | Standard Error 0.489 |
| Vortioxetine 10 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | -3.20 scores on a scale | Standard Error 0.321 |
| Vortioxetine 10 mg | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Week 4 (n=135, 133, 135, 127) | -11.88 scores on a scale | Standard Error 0.646 |
Secondary
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.
Time frame: Baseline and Weeks 1, 2, 4 and 6
Population: Full analysis set with available CGI-S data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 3.65 scores on a scale | Standard Error 0.053 |
| Placebo | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 2 (n=138, 138, 135, 135) | 3.40 scores on a scale | Standard Error 0.069 |
| Placebo | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 4 (n=135, 133, 135, 127) | 3.03 scores on a scale | Standard Error 0.082 |
| Placebo | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 6 (n=134, 130, 129, 126) | 2.95 scores on a scale | Standard Error 0.087 |
| Vortioxetine 1 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 2 (n=138, 138, 135, 135) | 3.16 scores on a scale | Standard Error 0.07 |
| Vortioxetine 1 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 4 (n=135, 133, 135, 127) | 2.69 scores on a scale | Standard Error 0.083 |
| Vortioxetine 1 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 6 (n=134, 130, 129, 126) | 2.48 scores on a scale | Standard Error 0.088 |
| Vortioxetine 1 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 3.71 scores on a scale | Standard Error 0.054 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 4 (n=135, 133, 135, 127) | 2.82 scores on a scale | Standard Error 0.083 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 2 (n=138, 138, 135, 135) | 3.19 scores on a scale | Standard Error 0.07 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 6 (n=134, 130, 129, 126) | 2.50 scores on a scale | Standard Error 0.088 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 3.67 scores on a scale | Standard Error 0.053 |
| Vortioxetine 10 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 6 (n=134, 130, 129, 126) | 2.37 scores on a scale | Standard Error 0.089 |
| Vortioxetine 10 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 2 (n=138, 138, 135, 135) | 3.23 scores on a scale | Standard Error 0.07 |
| Vortioxetine 10 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 3.64 scores on a scale | Standard Error 0.053 |
| Vortioxetine 10 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 4 (n=135, 133, 135, 127) | 2.78 scores on a scale | Standard Error 0.084 |
Secondary
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.
Time frame: Baseline to Week 8
Population: Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Clinical Global Impression Scale-Global Improvement at Week 8 | 2.84 scores on a scale | Standard Error 0.089 |
| Vortioxetine 1 mg | Clinical Global Impression Scale-Global Improvement at Week 8 | 2.37 scores on a scale | Standard Error 0.09 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Week 8 | 2.37 scores on a scale | Standard Error 0.089 |
| Vortioxetine 10 mg | Clinical Global Impression Scale-Global Improvement at Week 8 | 2.29 scores on a scale | Standard Error 0.091 |
p-value: <0.00195% CI: [-0.8, -0.3]Mixed model repeated measurements
p-value: <0.00195% CI: [-0.71, -0.22]Mixed model repeated measurements
p-value: <0.00195% CI: [-0.72, -0.23]Mixed model repeated measurements
Secondary
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.
Time frame: Baseline and Week 8
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any resource use | 62 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any hospitalization-related services | 4 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Hospitalization related to depression | 3 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any sick leave | 17 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Sick leave related to depression | 12 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any resource use | 31 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any hospitalization-related service | 3 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Hospitalization related to depression | 0 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any sick leave | 16 participants |
| Placebo | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Sick leave related to depression | 13 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Hospitalization related to depression | 3 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any sick leave | 6 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any sick leave | 7 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Sick leave related to depression | 6 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any resource use | 13 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any hospitalization-related service | 0 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Sick leave related to depression | 6 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Hospitalization related to depression | 0 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any resource use | 64 participants |
| Vortioxetine 1 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any hospitalization-related services | 3 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Hospitalization related to depression | 1 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any hospitalization-related service | 1 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Sick leave related to depression | 9 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any resource use | 71 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any sick leave | 14 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any resource use | 25 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any sick leave | 11 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any hospitalization-related services | 6 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Sick leave related to depression | 10 participants |
| Vortioxetine 5 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Hospitalization related to depression | 4 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Sick leave related to depression | 18 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Hospitalization related to depression | 0 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any resource use | 25 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Sick leave related to depression | 14 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any hospitalization-related service | 2 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any hospitalization-related services | 4 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Hospitalization related to depression | 2 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any sick leave | 21 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Baseline: Any resource use | 61 participants |
| Vortioxetine 10 mg | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. | Week 8: Any sick leave | 18 participants |
Secondary
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.
Time frame: Weeks 1, 2, 4 and 6
Population: Full analysis set with available data at Week 1; Last observation carried forward was used for other time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 0.7 percentage of participants |
| Placebo | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 2 (n=139, 139, 139, 139) | 2.2 percentage of participants |
| Placebo | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 4 (n=139, 139, 139, 139) | 6.5 percentage of participants |
| Placebo | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 6 (n=139, 139, 139, 139) | 10.1 percentage of participants |
| Vortioxetine 1 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 2 (n=139, 139, 139, 139) | 2.2 percentage of participants |
| Vortioxetine 1 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 4 (n=139, 139, 139, 139) | 11.5 percentage of participants |
| Vortioxetine 1 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 6 (n=139, 139, 139, 139) | 20.1 percentage of participants |
| Vortioxetine 1 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 0.7 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 4 (n=139, 139, 139, 139) | 11.5 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 2 (n=139, 139, 139, 139) | 1.4 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 6 (n=139, 139, 139, 139) | 20.9 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 0 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 6 (n=139, 139, 139, 139) | 22.3 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 2 (n=139, 139, 139, 139) | 1.4 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 0 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants in MADRS Remission at Other Weeks Assessed | Week 4 (n=139, 139, 139, 139) | 10.8 percentage of participants |
Secondary
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.
Time frame: Week 8
Population: Full analysis set; LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in MADRS Remission at Week 8 | 16.5 percentage of participants |
| Vortioxetine 1 mg | Percentage of Participants in MADRS Remission at Week 8 | 25.9 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in MADRS Remission at Week 8 | 28.8 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants in MADRS Remission at Week 8 | 26.6 percentage of participants |
p-value: 0.02695% CI: [1.082, 3.517]Regression, Logistic
p-value: 0.01595% CI: [1.15, 3.673]Regression, Logistic
p-value: 0.06295% CI: [0.973, 3.158]Regression, Logistic
Secondary
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.
Time frame: From Baseline through Week 8
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Sustained Response in HAM-D24 Total Score | 10.1 percentage of participants |
| Vortioxetine 1 mg | Percentage of Participants With a Sustained Response in HAM-D24 Total Score | 9.4 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants With a Sustained Response in HAM-D24 Total Score | 10.1 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants With a Sustained Response in HAM-D24 Total Score | 10.8 percentage of participants |
Secondary
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.
Time frame: Baseline and Weeks 1, 2, 4 and 6
Population: Full analysis set with available data at Week 1; Last observation carried forward (LOCF) was used for other time points. n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 0.7 percentage of participants |
| Placebo | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 2 (n=139, 139, 139, 139) | 5.0 percentage of participants |
| Placebo | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 4 (n=139, 139, 139, 139) | 18.0 percentage of participants |
| Placebo | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 6 (n=139, 139, 139, 139) | 23.7 percentage of participants |
| Vortioxetine 1 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 2 (n=139, 139, 139, 139) | 7.9 percentage of participants |
| Vortioxetine 1 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 4 (n=139, 139, 139, 139) | 27.3 percentage of participants |
| Vortioxetine 1 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 6 (n=139, 139, 139, 139) | 38.1 percentage of participants |
| Vortioxetine 1 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 0.7 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 4 (n=139, 139, 139, 139) | 24.5 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 2 (n=139, 139, 139, 139) | 7.2 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 6 (n=139, 139, 139, 139) | 36.0 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 0.7 percentage of participants |
| Vortioxetine 10 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 6 (n=139, 139, 139, 139) | 43.9 percentage of participants |
| Vortioxetine 10 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 2 (n=139, 139, 139, 139) | 8.6 percentage of participants |
| Vortioxetine 10 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 1 (n=139, 137, 138, 138) | 1.4 percentage of participants |
| Vortioxetine 10 mg | Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed | Week 4 (n=139, 139, 139, 139) | 26.6 percentage of participants |
Secondary
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.
Time frame: Baseline and Week 8
Population: Full analysis set; last observation carried forward (LOCF) was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders in HAM-D24 Total Score at Week 8 | 23.0 percentage of participants |
| Vortioxetine 1 mg | Percentage of Responders in HAM-D24 Total Score at Week 8 | 47.5 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-D24 Total Score at Week 8 | 45.3 percentage of participants |
| Vortioxetine 10 mg | Percentage of Responders in HAM-D24 Total Score at Week 8 | 49.6 percentage of participants |
p-value: <0.00195% CI: [1.995, 5.618]Regression, Logistic
p-value: <0.00195% CI: [1.631, 4.598]Regression, Logistic
p-value: <0.00195% CI: [1.799, 5.063]Regression, Logistic