Major Depressive Disorder
Conditions
Keywords
Major depressive disorder, Placebo-controlled, Active reference, Multicenter study, Randomised study, Acute treatment
Brief summary
The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).
Interventions
DRUGPlacebo
capsules; daily; orally
2.5 mg/day; encapsulated tablets; orally
DRUGDuloxetine
60 mg/day; encapsulated capsules; orally
Sponsors
H. Lundbeck A/S
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
* MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx) * Moderate to severe depression * Current MDE duration of at least 3 months
Exclusion criteria
* Any current psychiatric disorder other than MDD as defined in the DSM-IV TR * Any substance disorder within the previous 6 months * Female patients of childbearing potential who are not using effective contraception * Use of any psychoactive medication 2 weeks prior to screening and during the study Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | Baseline and Week 8 | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | Week 8 | — |
| Change in Clinical Status Using CGI-I Score at Week 8 | Week 8 | The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. |
| Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 | Baseline and Week 8 | — |
| Change From Baseline in SDS Total Score After 8 Weeks of Treatment | Baseline and Week 8 | The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. |
| Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | Baseline and Week 8 | The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. |
| Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | Baseline and Week 8 | The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. |
| Change From Baseline in CGI-S Score After 8 Weeks of Treatment | Baseline and Week 8 | The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. |
| Change From Baseline in ASEX Total Score After 8 Weeks of Treatment | Baseline and Week 8 | The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction. |
| Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | Week 8 | — |
Participant flow
Recruitment details
The patients were recruited from psychiatric settings.
Pre-assignment details
The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind downtaper period (Week 9); and a 4-week Safety Follow-up Period - the 4-week period after completion/withdrawal (Weeks 9 to 12).
Participants by arm
| Arm | Count |
|---|---|
| Placebo capsules; daily; orally | 148 |
| Vortioxetine 2.5 mg encapsulated tablets; orally | 155 |
| Vortioxetine 5 mg encapsulated tablets; orally | 157 |
| Vortioxetine 10 mg encapsulated tablets; orally | 151 |
| Duloxetine 60 mg encapsulated capsules; orally | 155 |
| Total | 766 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Administrative or Other Reasons | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Adverse Event | 12 | 10 | 18 | 15 | 19 |
| Overall Study | Lack of Efficacy | 5 | 6 | 3 | 4 | 6 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 0 | 3 |
| Overall Study | Non-compliance With Study Product | 0 | 0 | 0 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 2 | 3 | 2 | 4 |
| Overall Study | Withdrawal of Consent | 8 | 6 | 8 | 11 | 8 |
Baseline characteristics
| Characteristic | Placebo | Vortioxetine 2.5 mg | Vortioxetine 5 mg | Vortioxetine 10 mg | Duloxetine 60 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 12.5 | 46.0 years STANDARD_DEVIATION 12.5 | 44.7 years STANDARD_DEVIATION 13.1 | 45.2 years STANDARD_DEVIATION 13.1 | 45.3 years STANDARD_DEVIATION 12 | 44.9 years STANDARD_DEVIATION 12.7 |
| CGI-S | 4.8 units on a scale STANDARD_DEVIATION 0.7 | 4.8 units on a scale STANDARD_DEVIATION 0.7 | 4.8 units on a scale STANDARD_DEVIATION 0.7 | 4.7 units on a scale STANDARD_DEVIATION 0.7 | 4.7 units on a scale STANDARD_DEVIATION 0.7 | 4.8 units on a scale STANDARD_DEVIATION 0.7 |
| HAM-A | 23.1 units on a scale STANDARD_DEVIATION 5.6 | 22.2 units on a scale STANDARD_DEVIATION 6.7 | 23.5 units on a scale STANDARD_DEVIATION 6.2 | 23.4 units on a scale STANDARD_DEVIATION 6.3 | 22.8 units on a scale STANDARD_DEVIATION 6.4 | 23.0 units on a scale STANDARD_DEVIATION 6.3 |
| HAM-D-24 | 29.8 units on a scale STANDARD_DEVIATION 5.1 | 29.6 units on a scale STANDARD_DEVIATION 5.8 | 31.3 units on a scale STANDARD_DEVIATION 5.8 | 30.4 units on a scale STANDARD_DEVIATION 5.4 | 29.9 units on a scale STANDARD_DEVIATION 5.8 | 30.2 units on a scale STANDARD_DEVIATION 5.6 |
| MADRS | 31.7 units on a scale STANDARD_DEVIATION 4.3 | 31.6 units on a scale STANDARD_DEVIATION 4 | 32.7 units on a scale STANDARD_DEVIATION 4.8 | 31.8 units on a scale STANDARD_DEVIATION 3.9 | 31.4 units on a scale STANDARD_DEVIATION 4.2 | 31.9 units on a scale STANDARD_DEVIATION 4.3 |
| SDS | 19.9 units on a scale STANDARD_DEVIATION 5.8 | 19.4 units on a scale STANDARD_DEVIATION 6.5 | 19.6 units on a scale STANDARD_DEVIATION 6.2 | 19.6 units on a scale STANDARD_DEVIATION 6.5 | 19.2 units on a scale STANDARD_DEVIATION 5.9 | 19.6 units on a scale STANDARD_DEVIATION 6.2 |
| Sex: Female, Male Female | 103 Participants | 110 Participants | 104 Participants | 100 Participants | 105 Participants | 522 Participants |
| Sex: Female, Male Male | 45 Participants | 45 Participants | 53 Participants | 51 Participants | 50 Participants | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 64 / 148 | 61 / 155 | 63 / 157 | 62 / 151 | 93 / 155 |
| serious Total, serious adverse events | 3 / 148 | 1 / 155 | 3 / 157 | 2 / 151 | 2 / 155 |
Outcome results
Primary
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
Time frame: Baseline and Week 8
Population: Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | -14.8 units on a scale | Standard Error 0.82 |
| Vortioxetine 2.5 mg | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | -16.2 units on a scale | Standard Error 0.79 |
| Vortioxetine 5 mg | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | -16.5 units on a scale | Standard Error 0.8 |
| Vortioxetine 10 mg | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | -16.3 units on a scale | Standard Error 0.8 |
| Duloxetine 60 mg | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | -16.8 units on a scale | Standard Error 0.81 |
Comparison: As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.p-value: 0.132195% CI: [-3.92, 0.51]ANCOVA
Comparison: As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.p-value: 0.184795% CI: [-3.73, 0.72]ANCOVA
p-value: 0.218795% CI: [-3.59, 0.82]ANCOVA
p-value: 0.074195% CI: [-4.27, 0.2]ANCOVA
Secondary
Change From Baseline in ASEX Total Score After 8 Weeks of Treatment
The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.
Time frame: Baseline and Week 8
Population: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in ASEX Total Score After 8 Weeks of Treatment | -0.41 units on a scale | Standard Error 0.65 |
| Vortioxetine 2.5 mg | Change From Baseline in ASEX Total Score After 8 Weeks of Treatment | -0.53 units on a scale | Standard Error 0.62 |
| Vortioxetine 5 mg | Change From Baseline in ASEX Total Score After 8 Weeks of Treatment | -0.66 units on a scale | Standard Error 0.64 |
| Vortioxetine 10 mg | Change From Baseline in ASEX Total Score After 8 Weeks of Treatment | -0.62 units on a scale | Standard Error 0.62 |
| Duloxetine 60 mg | Change From Baseline in ASEX Total Score After 8 Weeks of Treatment | -0.38 units on a scale | Standard Error 0.64 |
p-value: 0.778995% CI: [-1.93, 1.45]ANCOVA
p-value: 0.812195% CI: [-1.91, 1.5]ANCOVA
p-value: 0.891895% CI: [-1.82, 1.59]ANCOVA
p-value: 0.97295% CI: [-1.69, 1.75]ANCOVA
Secondary
Change From Baseline in CGI-S Score After 8 Weeks of Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
Time frame: Baseline and Week 8
Population: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in CGI-S Score After 8 Weeks of Treatment | -1.64 units on a scale | Standard Error 0.11 |
| Vortioxetine 2.5 mg | Change From Baseline in CGI-S Score After 8 Weeks of Treatment | -1.83 units on a scale | Standard Error 0.1 |
| Vortioxetine 5 mg | Change From Baseline in CGI-S Score After 8 Weeks of Treatment | -1.81 units on a scale | Standard Error 0.1 |
| Vortioxetine 10 mg | Change From Baseline in CGI-S Score After 8 Weeks of Treatment | -1.83 units on a scale | Standard Error 0.1 |
| Duloxetine 60 mg | Change From Baseline in CGI-S Score After 8 Weeks of Treatment | -1.82 units on a scale | Standard Error 0.1 |
p-value: 0.228595% CI: [-0.46, 0.11]ANCOVA
p-value: 0.179495% CI: [-0.48, 0.09]ANCOVA
p-value: 0.174195% CI: [-0.48, 0.09]ANCOVA
p-value: 0.224795% CI: [-0.46, 0.11]ANCOVA
Secondary
Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.
Time frame: Baseline and Week 8
Population: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | -9.57 units on a scale | Standard Error 0.63 |
| Vortioxetine 2.5 mg | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | -9.87 units on a scale | Standard Error 0.61 |
| Vortioxetine 5 mg | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | -10.7 units on a scale | Standard Error 0.61 |
| Vortioxetine 10 mg | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | -10.6 units on a scale | Standard Error 0.62 |
| Duloxetine 60 mg | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | -11.0 units on a scale | Standard Error 0.62 |
p-value: 0.192595% CI: [-2.82, 0.57]ANCOVA
p-value: 0.243495% CI: [-2.72, 0.69]ANCOVA
p-value: 0.724695% CI: [-2, 1.39]ANCOVA
p-value: 0.098195% CI: [-3.16, 0.27]ANCOVA
Secondary
Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Time frame: Baseline and Week 8
Population: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | -13.3 units on a scale | Standard Error 0.82 |
| Vortioxetine 2.5 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | -14.4 units on a scale | Standard Error 0.79 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | -15.0 units on a scale | Standard Error 0.8 |
| Vortioxetine 10 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | -14.9 units on a scale | Standard Error 0.8 |
| Duloxetine 60 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | -15.7 units on a scale | Standard Error 0.81 |
p-value: 0.11295% CI: [-4.01, 0.42]ANCOVA
p-value: 0.148795% CI: [-3.85, 0.59]ANCOVA
p-value: 0.324695% CI: [-3.31, 1.1]ANCOVA
p-value: 0.029895% CI: [-4.7, -0.24]ANCOVA
Secondary
Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20
Time frame: Baseline and Week 8
Population: Patients With Baseline HAM-A Total Score \>=20: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 | -14.7 units on a scale | Standard Error 1.1 |
| Vortioxetine 2.5 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 | -14.3 units on a scale | Standard Error 1.15 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 | -15.8 units on a scale | Standard Error 1.09 |
| Vortioxetine 10 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 | -15.8 units on a scale | Standard Error 1.07 |
| Duloxetine 60 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 | -17.3 units on a scale | Standard Error 1.14 |
p-value: 0.809395% CI: [-2.65, 3.4]ANCOVA
p-value: 0.089795% CI: [-5.61, 0.41]ANCOVA
p-value: 0.442195% CI: [-4.08, 1.79]ANCOVA
p-value: 0.439995% CI: [-4.07, 1.77]ANCOVA
Secondary
Change From Baseline in SDS Total Score After 8 Weeks of Treatment
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.
Time frame: Baseline and Week 8
Population: SDS is a patient-reported outcome. The SDS Total Score is the sum of work, social life, or leisure activities, and home life or family responsibilities. FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SDS Total Score After 8 Weeks of Treatment | -6.11 units on a scale | Standard Error 0.72 |
| Vortioxetine 2.5 mg | Change From Baseline in SDS Total Score After 8 Weeks of Treatment | -7.10 units on a scale | Standard Error 0.74 |
| Vortioxetine 5 mg | Change From Baseline in SDS Total Score After 8 Weeks of Treatment | -6.52 units on a scale | Standard Error 0.73 |
| Vortioxetine 10 mg | Change From Baseline in SDS Total Score After 8 Weeks of Treatment | -7.81 units on a scale | Standard Error 0.74 |
| Duloxetine 60 mg | Change From Baseline in SDS Total Score After 8 Weeks of Treatment | -7.91 units on a scale | Standard Error 0.76 |
p-value: 0.674895% CI: [-2.35, 1.52]ANCOVA
p-value: 0.087195% CI: [-3.64, 0.25]ANCOVA
p-value: 0.318695% CI: [-2.94, 0.96]ANCOVA
p-value: 0.076895% CI: [-3.79, 0.19]ANCOVA
Secondary
Change in Clinical Status Using CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.
Time frame: Week 8
Population: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Clinical Status Using CGI-I Score at Week 8 | 2.52 units on a scale | Standard Error 0.1 |
| Vortioxetine 2.5 mg | Change in Clinical Status Using CGI-I Score at Week 8 | 2.32 units on a scale | Standard Error 0.1 |
| Vortioxetine 5 mg | Change in Clinical Status Using CGI-I Score at Week 8 | 2.32 units on a scale | Standard Error 0.1 |
| Vortioxetine 10 mg | Change in Clinical Status Using CGI-I Score at Week 8 | 2.35 units on a scale | Standard Error 0.1 |
| Duloxetine 60 mg | Change in Clinical Status Using CGI-I Score at Week 8 | 2.31 units on a scale | Standard Error 0.1 |
p-value: 0.143695% CI: [-0.47, 0.07]ANCOVA
p-value: 0.211495% CI: [-0.44, 0.1]ANCOVA
p-value: 0.138995% CI: [-0.47, 0.07]ANCOVA
p-value: 0.127195% CI: [-0.48, 0.06]ANCOVA
Secondary
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
Time frame: Week 8
Population: FAS; LOCF; Logistic Regression
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | 33.8 percentage of patients |
| Vortioxetine 2.5 mg | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | 32.9 percentage of patients |
| Vortioxetine 5 mg | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | 36.1 percentage of patients |
| Vortioxetine 10 mg | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | 35.8 percentage of patients |
| Duloxetine 60 mg | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | 34.9 percentage of patients |
p-value: 0.625895% CI: [0.7, 1.81]Adjusting for Baseline
p-value: 0.717895% CI: [0.68, 1.76]Adjusting for Baseline
p-value: 0.865195% CI: [0.59, 1.55]Adjusting for Baseline
p-value: 0.856395% CI: [0.65, 1.69]Adjusting for Baseline
Secondary
Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
Time frame: Week 8
Population: FAS; LOCF; Logistic Regression
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | 46.9 percentage of patients |
| Vortioxetine 2.5 mg | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | 54.2 percentage of patients |
| Vortioxetine 5 mg | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | 56.1 percentage of patients |
| Vortioxetine 10 mg | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | 57.6 percentage of patients |
| Duloxetine 60 mg | Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | 57.1 percentage of patients |
p-value: 0.13795% CI: [0.9, 2.23]Adjusting for Baseline
p-value: 0.066495% CI: [0.97, 2.43]Adjusting for Baseline
p-value: 0.202395% CI: [0.85, 2.12]Adjusting for Baseline
p-value: 0.076595% CI: [0.96, 2.4]Adjusting for Baseline