Major Depressive Disorder
Conditions
Keywords
Depression, Elderly, Acute treatment
Brief summary
To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.
Interventions
DRUGPlacebo
capsules; daily; orally
encapsulated tablets; daily; orally
DRUGDuloxetine
encapsulated tablets; daily; 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
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with: * Reported duration of the current episode of at least 4 weeks * MADRS total score \>=26 * At least one previous MDE before the age of 60 years
Exclusion criteria
* Mini Mental State Exam (MMSE) \<24 * Any current anxiety disorder as defined in the DSM-IV-TR * Current or past history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR * Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR * Presence or history of a clinically significant neurological disorder (including epilepsy) * Neurodegenerative disorder (Alzheimer's disease, Parkinson disease, multiple sclerosis, Huntington disease, etc) * Any Axis II disorder that might compromise the study * Significant risk of suicide according to the investigator's opinion, or has a score \>=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment | Baseline and Week 4 | — |
| Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment | Baseline and Week 2 | — |
| Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment | Baseline and Week 1 | — |
| 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. |
| 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 HAM-D-24 Total Score After 6 Weeks of Treatment | Baseline and Week 6 | — |
| 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 GDS Total Score After 8 Weeks of Treatment | Baseline and Week 8 | The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity. |
| Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) | Week 8 | — |
| Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | Week 8 | — |
| Risk of Suicidality Using C-SSRS Scores | Up to 8 weeks | The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient. |
| 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. |
Participant flow
Recruitment details
Patients were mainly recruited via psychiatric, psycho-geriatric, and geriatric inpatient or outpatient settings.
Pre-assignment details
The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind down-taper period (Week 9); and a 4-week Safety Follow-up Period after completion/withdrawal (Weeks 8 to 12).
Participants by arm
| Arm | Count |
|---|---|
| Placebo capsules; daily; orally | 145 |
| Vortioxetine 5 mg encapsulated tablets; daily; orally | 156 |
| Duloxetine 60 mg encapsulated tablets; daily; orally | 151 |
| Total | 452 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative or Other Reasons | 0 | 3 | 2 |
| Overall Study | Adverse Event | 6 | 10 | 15 |
| Overall Study | Lack of Efficacy | 7 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 3 | 3 | 2 |
| Overall Study | Withdrawal of Consent | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo | Vortioxetine 5 mg | Duloxetine 60 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 4.4 | 70.5 years STANDARD_DEVIATION 4.8 | 70.9 years STANDARD_DEVIATION 5.5 | 70.6 years STANDARD_DEVIATION 4.9 |
| CGI-S | 4.7 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 0.8 | 4.7 units on a scale STANDARD_DEVIATION 0.7 |
| GDS | 7.7 units on a scale STANDARD_DEVIATION 2 | 7.4 units on a scale STANDARD_DEVIATION 2.2 | 7.7 units on a scale STANDARD_DEVIATION 2.3 | 7.6 units on a scale STANDARD_DEVIATION 2.2 |
| HAM-A | 19.5 units on a scale STANDARD_DEVIATION 5.7 | 19.9 units on a scale STANDARD_DEVIATION 5.8 | 19.2 units on a scale STANDARD_DEVIATION 6.5 | 19.5 units on a scale STANDARD_DEVIATION 6 |
| HAM-D-24 | 29.4 units on a scale STANDARD_DEVIATION 5.1 | 29.2 units on a scale STANDARD_DEVIATION 5 | 28.5 units on a scale STANDARD_DEVIATION 4.9 | 29.0 units on a scale STANDARD_DEVIATION 5 |
| MADRS | 30.3 units on a scale STANDARD_DEVIATION 3.2 | 30.7 units on a scale STANDARD_DEVIATION 3.6 | 30.4 units on a scale STANDARD_DEVIATION 3.1 | 30.5 units on a scale STANDARD_DEVIATION 3.3 |
| Sex: Female, Male Female | 90 Participants | 107 Participants | 100 Participants | 297 Participants |
| Sex: Female, Male Male | 55 Participants | 49 Participants | 51 Participants | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 63 / 145 | 72 / 156 | 104 / 151 |
| serious Total, serious adverse events | 4 / 145 | 1 / 156 | 1 / 151 |
Outcome results
Primary
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: 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 HAM-D-24 Total Score After 8 Weeks of Treatment | -10.3 units on a scale | Standard Error 0.76 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | -13.7 units on a scale | Standard Error 0.74 |
| Duloxetine 60 mg | Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment | -15.8 units on a scale | Standard Error 0.75 |
Comparison: As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.p-value: 0.001195% CI: [-5.31, -1.34]ANCOVA
p-value: <0.000195% CI: [-7.5, -3.46]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 | -1.03 units on a scale | Standard Error 0.11 |
| Vortioxetine 5 mg | Change From Baseline in CGI-S Score After 8 Weeks of Treatment | -1.63 units on a scale | Standard Error 0.1 |
| Duloxetine 60 mg | Change From Baseline in CGI-S Score After 8 Weeks of Treatment | -2.05 units on a scale | Standard Error 0.11 |
p-value: <0.000195% CI: [-0.88, -0.32]ANCOVA
Secondary
Change From Baseline in GDS Total Score After 8 Weeks of Treatment
The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.
Time frame: Baseline and Week 8
Population: FAS; observed cases (OC); ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in GDS Total Score After 8 Weeks of Treatment | -0.65 units on a scale | Standard Error 0.17 |
| Vortioxetine 5 mg | Change From Baseline in GDS Total Score After 8 Weeks of Treatment | -1.08 units on a scale | Standard Error 0.17 |
| Duloxetine 60 mg | Change From Baseline in GDS Total Score After 8 Weeks of Treatment | -1.32 units on a scale | Standard Error 0.17 |
p-value: 0.055295% CI: [-0.88, 0.01]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 | -5.74 units on a scale | Standard Error 0.55 |
| Vortioxetine 5 mg | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | -8.09 units on a scale | Standard Error 0.54 |
| Duloxetine 60 mg | Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment | -9.28 units on a scale | Standard Error 0.54 |
p-value: 0.001595% CI: [-3.8, -0.91]ANCOVA
Secondary
Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment
Time frame: Baseline and Week 1
Population: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment | -3.62 units on a scale | Standard Error 0.41 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment | -4.04 units on a scale | Standard Error 0.4 |
| Duloxetine 60 mg | Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment | -3.48 units on a scale | Standard Error 0.41 |
p-value: 0.448295% CI: [-1.49, 0.66]ANCOVA
p-value: 0.797195% CI: [-0.95, 1.24]ANCOVA
Secondary
Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment
Time frame: Baseline and Week 2
Population: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment | -6.66 units on a scale | Standard Error 0.53 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment | -6.95 units on a scale | Standard Error 0.51 |
| Duloxetine 60 mg | Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment | -7.91 units on a scale | Standard Error 0.52 |
p-value: 0.687995% CI: [-1.67, 1.1]ANCOVA
p-value: 0.082795% CI: [-2.65, 0.16]ANCOVA
Secondary
Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
Time frame: Baseline and Week 4
Population: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment | -8.99 units on a scale | Standard Error 0.64 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment | -10.1 units on a scale | Standard Error 0.62 |
| Duloxetine 60 mg | Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment | -12.3 units on a scale | Standard Error 0.63 |
p-value: 0.213495% CI: [-2.72, 0.61]ANCOVA
p-value: 0.000295% CI: [-4.99, -1.6]ANCOVA
Secondary
Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
Time frame: Baseline and Week 6
Population: FAS; LOCF, ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment | -10.2 units on a scale | Standard Error 0.71 |
| Vortioxetine 5 mg | Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment | -12.3 units on a scale | Standard Error 0.69 |
| Duloxetine 60 mg | Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment | -14.4 units on a scale | Standard Error 0.7 |
Comparison: As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.p-value: 0.02495% CI: [-3.98, -0.28]ANCOVA
p-value: <0.000195% CI: [-6.1, -2.34]ANCOVA
Secondary
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: FAS; LOCF; ANCOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | -11.2 units on a scale | Standard Error 0.77 |
| Vortioxetine 5 mg | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | -15.5 units on a scale | Standard Error 0.75 |
| Duloxetine 60 mg | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | -18.0 units on a scale | Standard Error 0.76 |
p-value: <0.000195% CI: [-6.32, -2.26]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 | 2.91 units on a scale | Standard Error 0.1 |
| Vortioxetine 5 mg | Change in Clinical Status Using CGI-I Score at Week 8 | 2.35 units on a scale | Standard Error 0.09 |
| Duloxetine 60 mg | Change in Clinical Status Using CGI-I Score at Week 8 | 2.07 units on a scale | Standard Error 0.1 |
p-value: <0.000195% CI: [-0.82, -0.31]ANCOVA
Secondary
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
Time frame: Week 8
Population: FAS; LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | 21 percentage of patients |
| Vortioxetine 5 mg | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | 34 percentage of patients |
| Duloxetine 60 mg | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | 47 percentage of patients |
p-value: 0.00995% CI: [0.27, 0.83]Regression, Logistic
Secondary
Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)
Time frame: Week 8
Population: FAS; LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) | 35 percentage of patients |
| Vortioxetine 5 mg | Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) | 53 percentage of patients |
| Duloxetine 60 mg | Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) | 63 percentage of patients |
p-value: 0.000895% CI: [0.26, 0.7]Regression, Logistic
Secondary
Risk of Suicidality Using C-SSRS Scores
The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.
Time frame: Up to 8 weeks
Population: C-SSRS Data by Columbia Classification Algorithm for Suicide Assessment (C-CASA) Category (APTS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Risk of Suicidality Using C-SSRS Scores | No ideation or behavior | 103 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Completed Suicide | 0 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Suicide Attempt | 0 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Preparatory Actions Toward Imminent Suicidal Behav | 0 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Passive | 8 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Nonspecific | 3 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method, but no intent | 0 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method and intent, but | 0 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method, intent, and pl | 0 participants |
| Placebo | Risk of Suicidality Using C-SSRS Scores | Self-Injurious Behavior Without Suicidal Intent | 0 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method, intent, and pl | 0 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | No ideation or behavior | 107 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Nonspecific | 0 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Passive | 14 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Completed Suicide | 0 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Self-Injurious Behavior Without Suicidal Intent | 0 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method and intent, but | 0 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Suicide Attempt | 0 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method, but no intent | 0 participants |
| Vortioxetine 5 mg | Risk of Suicidality Using C-SSRS Scores | Preparatory Actions Toward Imminent Suicidal Behav | 0 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method and intent, but | 0 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Preparatory Actions Toward Imminent Suicidal Behav | 0 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Passive | 7 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Nonspecific | 0 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method, intent, and pl | 0 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Suicidal Ideation: Active / Method, but no intent | 0 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | No ideation or behavior | 106 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Self-Injurious Behavior Without Suicidal Intent | 0 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Completed Suicide | 0 participants |
| Duloxetine 60 mg | Risk of Suicidality Using C-SSRS Scores | Suicide Attempt | 1 participants |