Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder
NCT01564862, Phase 2, Completed, Takeda; results first posted 2015-02-05
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder | ClinicalTrials.gov |
| NCT number | NCT01564862 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 602 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Takeda | ClinicalTrials.gov |
| Conditions | Depressive Disorder, Major | ClinicalTrials.gov |
| Interventions | vortioxetine (Lu AA21004), Duloxetine, Placebo | ClinicalTrials.gov |
| First posted | 2012-03-28 | ClinicalTrials.gov |
| Last updated | 2015-02-05 | ClinicalTrials.gov |
| Other registries' IDs | eudract:2011-005298-22 | ClinicalTrials.gov |
| Results first posted | 2015-02-05 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST) | Baseline and Week 8 | The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with treatment and center as fixed factors and the Baseline value as a covariate. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore | Baseline and Week 8 | PDQ is a patient-rated scale designed to subjectively assess cognitive dysfunction, comprising four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization for a total possible score of 0 to 40. The subscale Attention/Concentration is the sum of items 1, 5, 9, 13, and 17 with a range of 0-20; while the subscale Planning/Organization is the sum of items 4, 8, 12, 16, and 20 with the score range of 0 to 20. The scores of the subscales Attention/Concentration and Planning/Organization were summed. Higher scores reflect greater participant-perceived cognitive dysfunction in the domains identified. A decrease in score represents an improvement in subjective cognitive function in the domains identified. A Mixed Model Repeated Measures (MMRM) model was used with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis. | ClinicalTrials.gov |
| Secondary | Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 | Baseline, Week 8 | The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator: "Compared to his condition at the start of the study, how much has this patient changed?" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. A MMRM model was used with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the Trail Making Test (TMT-A) | Baseline and Week 8 | The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower scores represent better speed of processing. A decrease in score over the study represents an improvement in speed in processing. An ANCOVA model was used with treatment and center as fixed factors and the baseline value as a covariate. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the Trail Making Test B (TMT-B) | Baseline and Week 8 | The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower score for TMT-B represents better executive function. A decrease in score over the study represents an improvement in executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. | ClinicalTrials.gov |
| Secondary | Change in Time From Baseline to Week 8 in the Stroop Test | Baseline and Week 8 | The STROOP test assesses the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises of 2 sheets with 50 words each, up to 50 correct responses for each of the congruent and incongruent Stroop tests. Participants have 4 minutes to name the ink color of each word. Lower time to complete the test indicates better performance. Higher number of correct responses indicates better responses. A decrease in the time to complete the tests and an increase in the number of correct responses both indicate improvement over the course of the study. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT) | Baseline and Week 8 | The GMLT measures executive functioning and spatial problem solving. Participants learn a hidden pathway through a maze of 10 x 10 grid of tiles on a computer touch screen using step-by-step guess, with trial and error feedback after each step. Once the pathway is learned, participants repeat the same pathway four more times. It usually takes 5-6 minutes to administer this test. Lower score equals better performance. A decrease in score over the course of the study indicates improved executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the Detection Task (DT) | Baseline and Week 8 | The DT is a computerized test that measures simple reaction time and psychomotor speed. The task requires participants to respond by pressing a "yes" button as soon as an onscreen playing card is turned over and is red, and by pressing a "no" button if the card is not red. It takes 2 minutes to be administered. There is no minimum or maximum scores since it is a time-based assessment. Lower score equals better performance. A decrease in score over the course of the study indicates improved speed of processing and psychomotor function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the Identification Task (IT) | Baseline and Week 8 | The IT measured choice reaction time: the participant pressed a "yes" button whenever an onscreen playing card turned face up and was red, or a "no" button if the card was not red. The IT took on average 2 minutes to complete. Lower scores equal better performance. A decrease in score over the course of the study indicates improved visual attention/vigilance. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the One-Back Task | Baseline and Week 8 | The One-Back test measures the cognitive domain of attention and working memory through yes or no responses to 30 trials. The task requires participants to report when a stimulus item presented serially is the same as an item one step back from the item at hand for a total correct responses 0 to 100. It usually takes 2-3 minutes to be administered. Higher scores equal better performance. An increase in score over the course of the study indicates improved attention/working memory. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate. | ClinicalTrials.gov |
| Secondary | Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression | Baseline and Week 8 | Improvement of Cognitive Dysfunction is determined using the change from Baseline to Week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score and the Digital Symbol Substitution Test (DSST) total number of correct symbols. The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression). The DSST assesses relative contributions of speed, memory, executive function and visual scanning. The proportion of direct effect from treatment = DSST difference / (DSST difference + coefficient\*MADRS difference). | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the MADRS Total Score | Baseline, Week 1, Week 4 and Week 8 | MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With MADRS Response at Week 8 | Baseline and Week 8 | MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Response was defined as a ≥50% decrease in MADRS Total Score from Baseline. | ClinicalTrials.gov |
| Secondary | Percentage of Participants in MADRS Remission at Week 8 | Week 8 | MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Remission was defined as a MADRS total score ≤10. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score | Baseline, Week 1, Week 4 and Week 8 | The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). A MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors was used for analyses. | ClinicalTrials.gov |
Outcomes 15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST) | Baseline and Week 8 | Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Participants with scores of \> 70 at Baseline were excluded. | Correct symbols | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore | Baseline and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis. | score on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 | Baseline, Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis. | score on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the Trail Making Test (TMT-A) | Baseline and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis. | seconds | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the Trail Making Test B (TMT-B) | Baseline and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis. | seconds | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Time From Baseline to Week 8 in the Stroop Test | Baseline and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis. | seconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT) | Baseline and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis. | Errors | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the Detection Task (DT) | Baseline and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis. | Log10 milliseconds | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the Identification Task (IT) | Baseline and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis. | Log10 milliseconds | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the One-Back Task | Baseline and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis. | Log 10 milliseconds | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression | Baseline and Week 8 | Full Analysis Set included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment. | proportion of direct effect | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the MADRS Total Score | Baseline, Week 1, Week 4 and Week 8 | Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Percentage of Participants With MADRS Response at Week 8 | Baseline and Week 8 | Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward. | percentage of participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Percentage of Participants in MADRS Remission at Week 8 | Week 8 | Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward. | percentage of participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score | Baseline, Week 1, Week 4 and Week 8 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis. Repeated Measures Analysis. | score on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
Results by group 59
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST) | Vortioxetine (Lu AA21004) | 4.60 | Standard Error 0.530 | Correct symbols | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST) | Duloxetine | 4.06 | Standard Error 0.511 | Correct symbols | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST) | Placebo | 2.85 | Standard Error 0.542 | Correct symbols | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore | Vortioxetine (Lu AA21004) | -8.9 | Standard Error 0.55 | score on a scale | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore | Duloxetine | -9.3 | Standard Error 0.53 | score on a scale | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore | Placebo | -6.3 | Standard Error 0.57 | score on a scale | ClinicalTrials.gov | |
| Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 | Vortioxetine (Lu AA21004) | 2.349 | Standard Error 0.0852 | score on a scale | ClinicalTrials.gov | |
| Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 | Duloxetine | 2.235 | Standard Error 0.0826 | score on a scale | ClinicalTrials.gov | |
| Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 | Placebo | 2.639 | Standard Error 0.0872 | score on a scale | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Trail Making Test (TMT-A) | Vortioxetine (Lu AA21004) | -7.70 | Standard Error 0.980 | seconds | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Trail Making Test (TMT-A) | Duloxetine | -8.06 | Standard Error 0.955 | seconds | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Trail Making Test (TMT-A) | Placebo | -6.65 | Standard Error 1.009 | seconds | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Trail Making Test B (TMT-B) | Vortioxetine (Lu AA21004) | -18.73 | Standard Error 2.096 | seconds | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Trail Making Test B (TMT-B) | Duloxetine | -14.60 | Standard Error 2.011 | seconds | ClinicalTrials.gov | |
| Change From Baseline to Week 8 in the Trail Making Test B (TMT-B) | Placebo | -9.06 | Standard Error 2.101 | seconds | ClinicalTrials.gov | |
| Change in Time From Baseline to Week 8 in the Stroop Test | Vortioxetine (Lu AA21004) | Congruent (n=174,187,167) | -3.30 | Standard Deviation 1.086 | seconds | ClinicalTrials.gov |
| Change in Time From Baseline to Week 8 in the Stroop Test | Duloxetine | Congruent (n=174,187,167) | -4.54 | Standard Deviation 1.044 | seconds | ClinicalTrials.gov |
| Change in Time From Baseline to Week 8 in the Stroop Test | Placebo | Congruent (n=174,187,167) | -4.37 | Standard Deviation 1.105 | seconds | ClinicalTrials.gov |
| Change in Time From Baseline to Week 8 in the Stroop Test | Vortioxetine (Lu AA21004) | Incongruent (n=172,186,166) | -8.17 | Standard Deviation 1.560 | seconds | ClinicalTrials.gov |
| Change in Time From Baseline to Week 8 in the Stroop Test | Duloxetine | Incongruent (n=172,186,166) | -9.83 | Standard Deviation 1.498 | seconds | ClinicalTrials.gov |
Participant flow 12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Vortioxetine (Lu AA21004) | 198 | ClinicalTrials.gov | |
| Overall Study | STARTED | Duloxetine | 210 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo | 194 | ClinicalTrials.gov | |
| Overall Study | Received Treatment | Vortioxetine (Lu AA21004) | 196 | ClinicalTrials.gov | |
| Overall Study | Received Treatment | Duloxetine | 207 | ClinicalTrials.gov | |
| Overall Study | Received Treatment | Placebo | 191 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Vortioxetine (Lu AA21004) | 168 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Duloxetine | 176 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 164 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Vortioxetine (Lu AA21004) | 30 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Duloxetine | 34 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 30 | ClinicalTrials.gov |
Adverse events 36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Vortioxetine (Lu AA21004) | 40 | 196 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | Duloxetine | 43 | 207 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | Placebo | 8 | 191 | ClinicalTrials.gov | |
| other | Diarrhoea | Gastrointestinal disorders | Vortioxetine (Lu AA21004) | 11 | 196 | ClinicalTrials.gov | |
| other | Diarrhoea | Gastrointestinal disorders | Duloxetine | 6 | 207 | ClinicalTrials.gov | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 191 | ClinicalTrials.gov | |
| other | Dry mouth | Gastrointestinal disorders | Vortioxetine (Lu AA21004) | 6 | 196 | ClinicalTrials.gov | |
| other | Dry mouth | Gastrointestinal disorders | Duloxetine | 16 | 207 | ClinicalTrials.gov | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 9 | 191 | ClinicalTrials.gov | |
| other | Nasopharyngitis | Infections and infestations | Vortioxetine (Lu AA21004) | 7 | 196 | ClinicalTrials.gov | |
| other | Nasopharyngitis | Infections and infestations | Duloxetine | 8 | 207 | ClinicalTrials.gov | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 11 | 191 | ClinicalTrials.gov | |
| other | Decreased appetite | Metabolism and nutrition disorders | Vortioxetine (Lu AA21004) | 3 | 196 | ClinicalTrials.gov | |
| other | Decreased appetite | Metabolism and nutrition disorders | Duloxetine | 12 | 207 | ClinicalTrials.gov | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 1 | 191 | ClinicalTrials.gov | |
| other | Headache | Nervous system disorders | Vortioxetine (Lu AA21004) | 20 | 196 | ClinicalTrials.gov | |
| other | Headache | Nervous system disorders | Duloxetine | 24 | 207 | ClinicalTrials.gov | |
| other | Headache | Nervous system disorders | Placebo | 16 | 191 | ClinicalTrials.gov | |
| other | Dizziness | Nervous system disorders | Vortioxetine (Lu AA21004) | 6 | 196 | ClinicalTrials.gov | |
| other | Dizziness | Nervous system disorders | Duloxetine | 11 | 207 | ClinicalTrials.gov |
Adverse event totals 9
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Vortioxetine (Lu AA21004) | ClinicalTrials.gov | ||
| Total, all-cause mortality | Duloxetine | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, other adverse events | Vortioxetine (Lu AA21004) | 73 | 196 | ClinicalTrials.gov |
| Total, other adverse events | Duloxetine | 84 | 207 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 41 | 191 | ClinicalTrials.gov |
| Total, serious adverse events | Vortioxetine (Lu AA21004) | 1 | 196 | ClinicalTrials.gov |
| Total, serious adverse events | Duloxetine | 1 | 207 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 2 | 191 | ClinicalTrials.gov |
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Symbol Coding | Primary outcome | ConductCognition |
| 1-Back Task | Secondary outcome | ConductCognition |
| Choice Reaction Time | Secondary outcome | ConductCognition |
| Hidden Path Learning | Secondary outcome | ConductCognition |
| Simple Reaction Time | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)