Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder, Mood Disorder, Affective Disorder, Anxiety Disorder, Drug Therapy
Brief summary
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.
Detailed description
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine. The study enrolled 304 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 5 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-center trial was conducted in the United States. The overall time to participate in this study was up to 13 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 vortioxetine immediate-release 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 No maximum
Healthy volunteers
No
Inclusion criteria
* Has a primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria. * Has a Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline. * Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline. * Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline.
Exclusion criteria
* Has 1 or more of the following: * Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview \[MINI\]). * 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® and subject must have a 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.). * Any Axis II disorder that might compromise the study. * Is taking excluded medications. * Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months. * 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. * Is 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 an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level greater than 1.5 times the upper limit of normal. * Has a serum creatinine of greater than 1.5 times the 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 at Screening and is deemed clinically significant by the investigator. * Has an abnormal electrocardiogram.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 | Baseline to Week 8 | The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8 | Baseline to Week 8 | The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM). |
| 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 were from a mixed model for repeated measurements (MMRM). |
| 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 were from a mixed model for repeated measurements (MMRM). |
| Percentage of Responders in HAM-A Total Score at Week 8 | Baseline and Week 8 | Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). |
| Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 | Baseline to Week 8 | The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8 | Baseline to Week 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 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 were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Baseline to Weeks 1, 2, 4 and 6. | The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed | Baseline to Weeks 1 and 4 | The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM). |
| Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Baseline to Weeks 1, 2, 4 and 6 | The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Baseline to Weeks 1, 2 and 4 | The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means and P-values were from a mixed model for repeated measurements (MMRM). |
| Percentage of Responders in HAM-A Total Score at Other Weeks Assessed | Baseline and Weeks 1, 2, 4 and 6 | Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). |
| Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Baseline to Weeks 1, 2, 4 and 6 | The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM). |
| Percentage of Participants in HAM-A Remission at Each Week Assessed | Weeks 1, 2, 4, 6 and 8 | Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity). |
| Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Baseline to 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 patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed | Baseline to Weeks 1, 4 and 8 | The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Baseline to 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 were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed | Baseline to 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 were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed | Baseline to 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 were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed | Baseline to 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 were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed | Baseline to 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 were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed | Baseline to 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 were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed | Baseline to 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 were from a mixed model for repeated measurements (MMRM). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed | Baseline to 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 were from a mixed model for repeated measurements (MMRM). |
| Health Care 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 33 investigative sites in the United States from 25 June 2008 to 06 March 2009.
Pre-assignment details
Participants with a diagnosis of generalized anxiety disorder were enrolled equally in one of two treatment groups, once a day placebo or 5 mg vortioxetine.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. | 152 |
| Vortioxetine 5 mg Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks. | 152 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Lack of Efficacy | 3 | 1 |
| Overall Study | Lost to Follow-up | 16 | 8 |
| Overall Study | Noncompliance | 2 | 2 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Protocol Deviations | 3 | 4 |
| Overall Study | Voluntary Withdrawal | 9 | 7 |
Baseline characteristics
| Characteristic | Placebo | Total | Vortioxetine 5 mg |
|---|---|---|---|
| Age Continuous | 41.4 years STANDARD_DEVIATION 12.81 | 41.2 years STANDARD_DEVIATION 13.42 | 41.0 years STANDARD_DEVIATION 14.05 |
| Age, Customized ≤55 years | 128 participants | 257 participants | 129 participants |
| Age, Customized >55 years | 24 participants | 47 participants | 23 participants |
| Alcohol Consumption 2 to 6 times per week | 27 participants | 54 participants | 27 participants |
| Alcohol Consumption Daily | 3 participants | 6 participants | 3 participants |
| Alcohol Consumption Never | 48 participants | 87 participants | 39 participants |
| Alcohol Consumption Once a week | 17 participants | 45 participants | 28 participants |
| Alcohol Consumption Once monthly or less often | 57 participants | 112 participants | 55 participants |
| Body Mass Index (BMI) | 29.66 kg/m^2 STANDARD_DEVIATION 6.861 | 29.04 kg/m^2 STANDARD_DEVIATION 6.789 | 28.42 kg/m^2 STANDARD_DEVIATION 6.68 |
| Clinical Global Impression - Severity scale score | 4.3 scores on a scale STANDARD_DEVIATION 0.49 | 4.3 scores on a scale STANDARD_DEVIATION 0.51 | 4.3 scores on a scale STANDARD_DEVIATION 0.53 |
| Hamilton Anxiety Scale Total Score | 24.6 scores on a scale STANDARD_DEVIATION 3.6 | 24.7 scores on a scale STANDARD_DEVIATION 3.69 | 24.7 scores on a scale STANDARD_DEVIATION 3.79 |
| Height | 167.73 cm STANDARD_DEVIATION 8.765 | 167.73 cm STANDARD_DEVIATION 8.949 | 167.72 cm STANDARD_DEVIATION 9.158 |
| Hospital Anxiety and Depression - Anxiety subscale | 13.5 scores on a scale STANDARD_DEVIATION 3.14 | 13.7 scores on a scale STANDARD_DEVIATION 3.26 | 13.8 scores on a scale STANDARD_DEVIATION 3.39 |
| Hospital Anxiety and Depression - Depression subscale | 8.5 scores on a scale STANDARD_DEVIATION 3.79 | 8.3 scores on a scale STANDARD_DEVIATION 3.85 | 8.1 scores on a scale STANDARD_DEVIATION 3.91 |
| Montgomery Åsberg Depression Rating Scale (MADRS) total score | 11.83 scores on a scale STANDARD_DEVIATION 3.007 | 11.96 scores on a scale STANDARD_DEVIATION 2.953 | 12.09 scores on a scale STANDARD_DEVIATION 2.902 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 5 participants | 3 participants |
| Race/Ethnicity, Customized Black | 17 participants | 41 participants | 24 participants |
| Race/Ethnicity, Customized Caucasian (White, including Hispanic) | 131 participants | 254 participants | 123 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 24 participants | 50 participants | 26 participants |
| Race/Ethnicity, Customized Native Hawaiian/ Other Pacific Islander | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Non-Hispanic/Non-Latino | 128 participants | 254 participants | 126 participants |
| Region of Enrollment United States | 152 participants | 304 participants | 152 participants |
| Sex: Female, Male Female | 97 Participants | 200 Participants | 103 Participants |
| Sex: Female, Male Male | 55 Participants | 104 Participants | 49 Participants |
| Smoking Classification Current Smoker | 38 participants | 81 participants | 43 participants |
| Smoking Classification Ex-smoker | 36 participants | 69 participants | 33 participants |
| Smoking Classification Never Smoked | 78 participants | 154 participants | 76 participants |
| Weight | 83.68 kg STANDARD_DEVIATION 20.916 | 81.89 kg STANDARD_DEVIATION 20.652 | 80.10 kg STANDARD_DEVIATION 20.296 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 65 / 151 | 89 / 148 |
| serious Total, serious adverse events | 3 / 151 | 1 / 148 |
Outcome results
Primary
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Week 8
Population: The Full Analysis Set 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 Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 | -13.16 scores on a scale | Standard Error 0.655 |
| Vortioxetine 5 mg | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 | -12.57 scores on a scale | Standard Error 0.646 |
Comparison: P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 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: 0.51895% CI: [-1.2, 2.38]Mixed model for repeated measurements
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 2, 4 and 8
Population: The 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 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed | Week 2 (n=137, 143) | 7.24 scores on a scale | Standard Error 1.743 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed | Week 4 (n=129, 134) | 9.81 scores on a scale | Standard Error 1.756 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed | Week 8 (n=113, 125) | 10.14 scores on a scale | Standard Error 1.965 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed | Week 2 (n=137, 143) | 6.49 scores on a scale | Standard Error 1.755 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed | Week 4 (n=129, 134) | 8.96 scores on a scale | Standard Error 1.761 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed | Week 8 (n=113, 125) | 8.58 scores on a scale | Standard Error 1.915 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 2, 4 and 8
Population: The 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 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed | Week 2 (n=137, 143) | 2.79 scores on a scale | Standard Error 1.095 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed | Week 4 (n=129, 134) | 4.85 scores on a scale | Standard Error 1.204 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed | Week 8 (n=113, 125) | 6.14 scores on a scale | Standard Error 1.391 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed | Week 2 (n=137, 143) | 3.61 scores on a scale | Standard Error 1.109 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed | Week 4 (n=129, 134) | 1.76 scores on a scale | Standard Error 1.212 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed | Week 8 (n=113, 125) | 3.90 scores on a scale | Standard Error 1.365 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 2, 4 and 8
Population: The 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 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed | Week 2 (n=137, 143) | 10.32 scores on a scale | Standard Error 1.455 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed | Week 4 (n=129, 134) | 12.58 scores on a scale | Standard Error 1.61 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed | Week 8 (n=113, 125) | 17.95 scores on a scale | Standard Error 1.716 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed | Week 2 (n=137, 143) | 11.72 scores on a scale | Standard Error 1.47 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed | Week 4 (n=129, 134) | 15.12 scores on a scale | Standard Error 1.617 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed | Week 8 (n=113, 125) | 16.91 scores on a scale | Standard Error 1.686 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 2, 4 and 8
Population: The 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 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed | Week 2 (n=137, 143) | 1.54 scores on a scale | Standard Error 1.322 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed | Week 4 (n=129, 134) | 4.76 scores on a scale | Standard Error 1.424 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed | Week 8 (n=113, 125) | 3.50 scores on a scale | Standard Error 1.64 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed | Week 2 (n=137, 143) | 3.69 scores on a scale | Standard Error 1.336 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed | Week 4 (n=129, 134) | 4.22 scores on a scale | Standard Error 1.432 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed | Week 8 (n=113, 125) | 4.18 scores on a scale | Standard Error 1.609 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 2, 4 and 8
Population: The 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 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed | Week 2 (n=137, 143) | 14.54 scores on a scale | Standard Error 2.028 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed | Week 4 (n=129, 134) | 16.00 scores on a scale | Standard Error 2.055 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed | Week 8 (n=113, 125) | 21.64 scores on a scale | Standard Error 2.202 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed | Week 2 (n=137, 143) | 13.25 scores on a scale | Standard Error 2.041 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed | Week 4 (n=129, 134) | 15.00 scores on a scale | Standard Error 2.063 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed | Week 8 (n=113, 125) | 19.01 scores on a scale | Standard Error 2.159 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 2, 4 and 8
Population: The 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 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed | Week 2 (n=137, 143) | 5.03 scores on a scale | Standard Error 1.901 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed | Week 4 (n=129, 134) | 8.65 scores on a scale | Standard Error 1.966 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed | Week 8 (n=113, 125) | 10.02 scores on a scale | Standard Error 1.998 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed | Week 2 (n=137, 143) | 4.90 scores on a scale | Standard Error 1.906 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed | Week 4 (n=129, 134) | 5.19 scores on a scale | Standard Error 1.967 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed | Week 8 (n=113, 125) | 7.74 scores on a scale | Standard Error 1.953 |
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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 2 and 4
Population: The 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 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 2 (n=137, 143) | 11.96 scores on a scale | Standard Error 1.803 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed | Week 4 (n=129, 134) | 17.12 scores on a scale | Standard Error 1.993 |
| 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=137, 143) | 14.06 scores on a scale | Standard Error 1.82 |
| 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=129, 134) | 16.22 scores on a scale | Standard Error 1.999 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 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 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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Week 8
Population: The 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 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8 | 17.43 scores on a scale | Standard Error 2.133 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8 | 18.44 scores on a scale | Standard Error 2.091 |
p-value: 0.73195% CI: [-4.79, 6.83]Mixed model for repeated measurements
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 2, 4 and 8
Population: The 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 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed | Week 2 (n=137, 143) | 8.91 scores on a scale | Standard Error 1.528 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed | Week 4 (n=129, 134) | 12.48 scores on a scale | Standard Error 1.655 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed | Week 8 (n=113, 125) | 16.06 scores on a scale | Standard Error 1.828 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed | Week 2 (n=137, 143) | 10.46 scores on a scale | Standard Error 1.555 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed | Week 4 (n=129, 134) | 12.67 scores on a scale | Standard Error 1.671 |
| Vortioxetine 5 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed | Week 8 (n=113, 125) | 14.65 scores on a scale | Standard Error 1.805 |
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 patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 1, 2, 4, 6 and 8
Population: Full analysis set. 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 2 (n=134, 142) | -0.75 scores on a scale | Standard Error 0.081 |
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 6 (n=124, 129) | -1.45 scores on a scale | Standard Error 0.098 |
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 4 (n=131, 135) | -1.15 scores on a scale | Standard Error 0.093 |
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 8 (n=113, 124) | -1.72 scores on a scale | Standard Error 0.104 |
| Placebo | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 1 (n=141, 144) | -0.37 scores on a scale | Standard Error 0.057 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 8 (n=113, 124) | -1.54 scores on a scale | Standard Error 0.102 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 1 (n=141, 144) | -0.38 scores on a scale | Standard Error 0.058 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 2 (n=134, 142) | -0.86 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 4 (n=131, 135) | -1.05 scores on a scale | Standard Error 0.092 |
| Vortioxetine 5 mg | Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed | Week 6 (n=124, 129) | -1.40 scores on a scale | Standard Error 0.097 |
Secondary
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 1, 2, 4 and 6.
Population: The Full Analysis Set. 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 Other Weeks Assessed | Week 1 (n=141, 144) | -4.84 scores on a scale | Standard Error 0.415 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Week 2 (n=134, 142) | -7.78 scores on a scale | Standard Error 0.542 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Week 4 (n=131, 135) | -10.13 scores on a scale | Standard Error 0.59 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Week 6 (n=124, 129) | -12.39 scores on a scale | Standard Error 0.632 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Week 6 (n=124, 129) | -11.61 scores on a scale | Standard Error 0.63 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Week 1 (n=141, 144) | -4.59 scores on a scale | Standard Error 0.422 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Week 4 (n=131, 135) | -9.82 scores on a scale | Standard Error 0.59 |
| Vortioxetine 5 mg | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Week 2 (n=134, 142) | -8.22 scores on a scale | Standard Error 0.541 |
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 and P-values were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 1, 2 and 4
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 Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 1 (n=117, 116) | -2.13 scores on a scale | Standard Error 0.484 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 2 (n=109, 114) | -4.35 scores on a scale | Standard Error 0.566 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 4 (n=106, 108) | -5.57 scores on a scale | Standard Error 0.587 |
| Vortioxetine 5 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 1 (n=117, 116) | -2.46 scores on a scale | Standard Error 0.497 |
| Vortioxetine 5 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 2 (n=109, 114) | -4.02 scores on a scale | Standard Error 0.572 |
| Vortioxetine 5 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed | Week 4 (n=106, 108) | -5.38 scores on a scale | Standard Error 0.593 |
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 were from a mixed model for repeated measurements (MMRM).
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 | -6.68 scores on a scale | Standard Error 0.618 |
| Vortioxetine 5 mg | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | -6.35 scores on a scale | Standard Error 0.616 |
p-value: 0.70395% CI: [-1.38, 2.04]Mixed model for repeated measurements
Secondary
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 1, 2, 4 and 6
Population: Full analysis set patients with a HAM-A Baseline score ≥25. 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 Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Week 1 (n=71, 71) | -5.39 scores on a scale | Standard Error 0.675 |
| Placebo | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Week 2 (n=70, 70) | -8.37 scores on a scale | Standard Error 0.889 |
| Placebo | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Week 4 (n=67, 67) | -10.90 scores on a scale | Standard Error 0.994 |
| Placebo | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Week 6 (n=63, 65) | -13.60 scores on a scale | Standard Error 1.04 |
| Vortioxetine 5 mg | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Week 6 (n=63, 65) | -12.82 scores on a scale | Standard Error 1.021 |
| Vortioxetine 5 mg | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Week 1 (n=71, 71) | -4.73 scores on a scale | Standard Error 0.648 |
| Vortioxetine 5 mg | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Week 4 (n=67, 67) | -10.74 scores on a scale | Standard Error 0.98 |
| Vortioxetine 5 mg | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 | Week 2 (n=70, 70) | -8.94 scores on a scale | Standard Error 0.873 |
Secondary
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Week 8
Population: Full analysis set patients with a HAM-A Baseline score ≥25. 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 Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 | -14.04 scores on a scale | Standard Error 1.104 |
| Vortioxetine 5 mg | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 | -14.05 scores on a scale | Standard Error 1.08 |
p-value: 0.99595% CI: [-3.09, 3.07]Mixed model for repeated measurements
Secondary
Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed
The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 1 and 4
Population: The 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 Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed | Week 1 (n=139, 142) | -1.81 scores on a scale | Standard Error 0.269 |
| Placebo | Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed | Week 4 (n=130, 135) | -3.41 scores on a scale | Standard Error 0.328 |
| Vortioxetine 5 mg | Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed | Week 1 (n=139, 142) | -2.07 scores on a scale | Standard Error 0.273 |
| Vortioxetine 5 mg | Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed | Week 4 (n=130, 135) | -3.72 scores on a scale | Standard Error 0.329 |
Secondary
Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8
The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Week 8
Population: The 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 the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8 | -4.84 scores on a scale | Standard Error 0.392 |
| Vortioxetine 5 mg | Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8 | -5.06 scores on a scale | Standard Error 0.384 |
Comparison: Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05).p-value: 0.68595% CI: [-1.29, 0.85]Mixed model for repeated measurements
Secondary
Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed
The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 1, 4 and 8
Population: The 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 Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed | Week 1 (n=139, 142) | -1.02 scores on a scale | Standard Error 0.226 |
| Placebo | Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed | Week 4 (n=130, 135) | -1.84 scores on a scale | Standard Error 0.273 |
| Placebo | Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed | Week 8 (n=111, 124) | -2.55 scores on a scale | Standard Error 0.316 |
| Vortioxetine 5 mg | Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed | Week 1 (n=139, 142) | -1.09 scores on a scale | Standard Error 0.228 |
| Vortioxetine 5 mg | Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed | Week 4 (n=130, 135) | -2.28 scores on a scale | Standard Error 0.273 |
| Vortioxetine 5 mg | Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed | Week 8 (n=111, 124) | -2.62 scores on a scale | Standard Error 0.308 |
Secondary
Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).
Time frame: Baseline to Weeks 1, 2, 4 and 6
Population: Full analysis set. 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=141, 144) | 3.32 scores on a scale | Standard Error 0.066 |
| Placebo | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 2 (n=134, 142) | 2.92 scores on a scale | Standard Error 0.081 |
| Placebo | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 4 (n=131, 135) | 2.57 scores on a scale | Standard Error 0.089 |
| Placebo | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 6 (n=124, 129) | 2.42 scores on a scale | Standard Error 0.096 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 6 (n=124, 129) | 2.39 scores on a scale | Standard Error 0.095 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 1 (n=141, 144) | 3.38 scores on a scale | Standard Error 0.066 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 4 (n=131, 135) | 2.57 scores on a scale | Standard Error 0.089 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed | Week 2 (n=134, 142) | 2.83 scores on a scale | Standard Error 0.081 |
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 were from a mixed model for repeated measurements (MMRM).
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 | 2.25 scores on a scale | Standard Error 0.101 |
| Vortioxetine 5 mg | Clinical Global Impression Scale-Global Improvement at Week 8 | 2.25 scores on a scale | Standard Error 0.099 |
p-value: 0.98495% CI: [-0.27, 0.28]Mixed model for repeated measurements
Secondary
Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.
Time frame: Baseline and Week 8
Population: Full analysis set with available data at Baseline (139 and 136 patients) and at Week 8 (122 and 131 patients).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Any resource use | 30 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Any hospitalization-related services | 1 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Hospitalization related to anxiety | 0 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Any sick leave | 8 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Sick leave related to anxiety | 7 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Any resource use | 22 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Any hospitalization-related service | 0 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Hospitalization related to anxiety | 0 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Any sick leave | 4 participants |
| Placebo | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Sick leave related to anxiety | 2 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Hospitalization related to anxiety | 0 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Any resource use | 30 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Any resource use | 19 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Any hospitalization-related services | 0 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Sick leave related to anxiety | 1 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Hospitalization related to anxiety | 0 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Any hospitalization-related service | 1 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Any sick leave | 10 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Week 8: Any sick leave | 6 participants |
| Vortioxetine 5 mg | Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Baseline: Sick leave related to anxiety | 4 participants |
Secondary
Percentage of Participants in HAM-A Remission at Each Week Assessed
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Time frame: Weeks 1, 2, 4, 6 and 8
Population: Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 2 (n=144, 145) | 5.6 percentage of participants |
| Placebo | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 6 (n=144, 145) | 22.2 percentage of participants |
| Placebo | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 4 (n=144, 145) | 15.3 percentage of participants |
| Placebo | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 8 (n=144, 145) | 22.2 percentage of participants |
| Placebo | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 1 (n-141, 144) | 2.1 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 8 (n=144, 145) | 25.5 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 1 (n-141, 144) | 0.7 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 2 (n=144, 145) | 7.6 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 4 (n=144, 145) | 12.4 percentage of participants |
| Vortioxetine 5 mg | Percentage of Participants in HAM-A Remission at Each Week Assessed | Week 6 (n=144, 145) | 22.1 percentage of participants |
Secondary
Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Time frame: Baseline and Weeks 1, 2, 4 and 6
Population: Full analysis set; Last observation carried forward was used; 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-A Total Score at Other Weeks Assessed | Week 1 (n=141, 144) | 9.9 percentage of participants |
| Placebo | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed | Week 2 (n=144, 145) | 22.9 percentage of participants |
| Placebo | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed | Week 4 (n=144, 145) | 34.7 percentage of participants |
| Placebo | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed | Week 6 (n=144, 145) | 47.2 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed | Week 6 (n=144, 145) | 45.5 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed | Week 1 (n=141, 144) | 6.9 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed | Week 4 (n=144, 145) | 37.2 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-A Total Score at Other Weeks Assessed | Week 2 (n=144, 145) | 24.1 percentage of participants |
Secondary
Percentage of Responders in HAM-A Total Score at Week 8
Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Time frame: Baseline and Week 8
Population: Full analysis set; Last observation carried forward was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders in HAM-A Total Score at Week 8 | 50.0 percentage of participants |
| Vortioxetine 5 mg | Percentage of Responders in HAM-A Total Score at Week 8 | 53.1 percentage of participants |
p-value: 0.60295% CI: [0.713, 1.795]Regression, Logistic