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Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder

NCT01422213, Phase 3, Completed, H. Lundbeck A/S; results first posted 2014-08-05

Trial 12

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleEfficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive DisorderClinicalTrials.gov
NCT numberNCT01422213ClinicalTrials.gov
StatusCompletedClinicalTrials.gov
PhasesPhase 3ClinicalTrials.gov
Enrollment598 participants, actualClinicalTrials.gov
Lead sponsorH. Lundbeck A/SClinicalTrials.gov
ConditionsMajor Depressive DisorderClinicalTrials.gov
InterventionsPlacebo, Vortioxetine (Lu AA21004), Vortioxetine (Lu AA21004)ClinicalTrials.gov
First posted2011-08-23ClinicalTrials.gov
Last updated2014-08-05ClinicalTrials.gov
Other registries' IDseudract:2011-001572-19ClinicalTrials.gov
Results first posted2014-08-05ClinicalTrials.gov

Registered outcomes 18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryChange From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scoresBaseline and Week 8
DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (\< normal functioning) to 133 (\> normal functioning). RAVLT assesses verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded. The scores are standardized by subtracting the overall mean change from baseline from the individual change from baseline and dividing by the standard deviation estimate of the change from baseline. The 2 tests, DSST and RAVLT are each assigned a weight of 0.5, the 2 subtests of RAVLT are each assigned a weight of 0.25.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in DSST (Number of Correct Symbols)Baseline and Week 8
Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in RAVLT (Acquisition)Baseline and Week 8
Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in RAVLT (Delayed Recall)Baseline and Week 8
Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in the TMT A (Speed of Processing)Baseline and Week 8
Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part A assesses cognitive processing speed. The lower the score the faster the processing speed.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in the TMT B (Executive Function)Baseline and Week 8
TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)Baseline and Week 8
Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function)Baseline and Week 8ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in the SRT (Speed of Processing)Baseline and Week 8
Simple Reaction Time (SRT) is designed to assess psychomotor speed, and Choice Reaction Time (CRT) is designed to assess visual attention. Two computerised tests, part of the CogState battery were used to measure SRT and CRT in milliseconds: * The "detection task" measures SRT: the patient presses a "yes" button, whenever an onscreen playing card is turned over. * The "identification task" measures CRT: the patient presses a "yes" button whenever an onscreen playing card is turned over and is red, or a "no" button if the card is not red.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in the CRT (Attention)Baseline and Week 8ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in MADRS Total ScoreBaseline 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.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 in CGI-S ScoreBaseline 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.
ClinicalTrials.gov
SecondaryClinical Status Using CGI-I Score at Week 8Week 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.
ClinicalTrials.gov
SecondaryProportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From BaselineBaseline and Week 8ClinicalTrials.gov
SecondaryProportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10)Week 8ClinicalTrials.gov
SecondaryChange From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-scoreBaseline and Week 1
Effect on cognitive dysfunction after correcting for the effect on depressive symptoms. The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables. In the week 1 analysis the vortioxetine 10 and 20 mg groups were pooled because patients randomized to vortioxetine 20 mg received vortioxetine 10 mg in the first week of the study.
ClinicalTrials.gov
SecondaryChange From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-scoreBaseline and Week 8
Effect on cognitive dysfunction after correcting for the effect on depressive symptoms. The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables.
ClinicalTrials.gov
SecondaryRisk of Suicidality Using C-SSRS ScoresUp 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 subquestions that assess severity. The tool was administered via an interview with the patient. For 2 patients in each treament group (6 in total) the CSSRS assessments are missing during study.
ClinicalTrials.gov

Outcomes 18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource
PRIMARYChange From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scoresBaseline and Week 8FASz scoreMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in DSST (Number of Correct Symbols)Baseline and Week 8FASnumber of correct symbolsMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in RAVLT (Acquisition)Baseline and Week 8FASnumber of words correctly recalledMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in RAVLT (Delayed Recall)Baseline and Week 8FASnumber of words correctly recalledMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in the TMT A (Speed of Processing)Baseline and Week 8FASsecondsMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in the TMT B (Executive Function)Baseline and Week 8FASsecondsMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)Baseline and Week 8FASsecondsMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function)Baseline and Week 8FASsecondsMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in the SRT (Speed of Processing)Baseline and Week 8FASlog10 (ms)MEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in the CRT (Attention)Baseline and Week 8FASlog10 (ms)MEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in MADRS Total ScoreBaseline and Week 8FASunits on a scaleMEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 in CGI-S ScoreBaseline and Week 8FASunits on a scaleMEANClinicalTrials.gov
SECONDARYClinical Status Using CGI-I Score at Week 8Week 8FASunits on a scaleMEANClinicalTrials.gov
SECONDARYProportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From BaselineBaseline and Week 8FAS, last observation carried forward (LOCF)percentage of participantsNUMBERClinicalTrials.gov
SECONDARYProportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10)Week 8FAS, LOCFpercentage of participantsNUMBERClinicalTrials.gov
SECONDARYChange From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-scoreBaseline and Week 1FAS, LOCFz scoreLEAST_SQUARES_MEANClinicalTrials.gov
SECONDARYChange From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-scoreBaseline and Week 8FAS, LOCFz scoreLEAST_SQUARES_MEANClinicalTrials.gov
SECONDARYRisk of Suicidality Using C-SSRS ScoresUp to 8 weeksAPTSparticipantsNUMBERClinicalTrials.gov

Results by group 59

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource
Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scoresPlacebo-0.235Standard Error 0.053z scoreClinicalTrials.gov
Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scoresVortioxetine 10 mg0.128Standard Error 0.052z scoreClinicalTrials.gov
Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scoresVortioxetine 20 mg0.095Standard Error 0.051z scoreClinicalTrials.gov
Change From Baseline to Week 8 in DSST (Number of Correct Symbols)Placebo4.83Standard Error 0.63number of correct symbolsClinicalTrials.gov
Change From Baseline to Week 8 in DSST (Number of Correct Symbols)Vortioxetine 10 mg9.03Standard Error 0.63number of correct symbolsClinicalTrials.gov
Change From Baseline to Week 8 in DSST (Number of Correct Symbols)Vortioxetine 20 mg9.09Standard Error 0.61number of correct symbolsClinicalTrials.gov
Change From Baseline to Week 8 in RAVLT (Acquisition)Placebo3.06Standard Error 0.34number of words correctly recalledClinicalTrials.gov
Change From Baseline to Week 8 in RAVLT (Acquisition)Vortioxetine 10 mg4.08Standard Error 0.34number of words correctly recalledClinicalTrials.gov
Change From Baseline to Week 8 in RAVLT (Acquisition)Vortioxetine 20 mg3.65Standard Error 0.33number of words correctly recalledClinicalTrials.gov
Change From Baseline to Week 8 in RAVLT (Delayed Recall)Placebo0.91Standard Error 0.18number of words correctly recalledClinicalTrials.gov
Change From Baseline to Week 8 in RAVLT (Delayed Recall)Vortioxetine 10 mg1.63Standard Error 0.18number of words correctly recalledClinicalTrials.gov
Change From Baseline to Week 8 in RAVLT (Delayed Recall)Vortioxetine 20 mg1.56Standard Error 0.17number of words correctly recalledClinicalTrials.gov
Change From Baseline to Week 8 in the TMT A (Speed of Processing)Placebo-7.07Standard Error 1.00secondsClinicalTrials.gov
Change From Baseline to Week 8 in the TMT A (Speed of Processing)Vortioxetine 10 mg-10.84Standard Error 1.00secondsClinicalTrials.gov
Change From Baseline to Week 8 in the TMT A (Speed of Processing)Vortioxetine 20 mg-10.87Standard Error 0.97secondsClinicalTrials.gov
Change From Baseline to Week 8 in the TMT B (Executive Function)Placebo-13.84Standard Error 2.00secondsClinicalTrials.gov
Change From Baseline to Week 8 in the TMT B (Executive Function)Vortioxetine 10 mg-21.41Standard Error 2.00secondsClinicalTrials.gov
Change From Baseline to Week 8 in the TMT B (Executive Function)Vortioxetine 20 mg-22.85Standard Error 1.95secondsClinicalTrials.gov
Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)Placebo-5.97Standard Error 0.93secondsClinicalTrials.gov
Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)Vortioxetine 10 mg-9.97Standard Error 0.93secondsClinicalTrials.gov

Participant flow 9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource
Overall StudySTARTEDPlacebo196ClinicalTrials.gov
Overall StudySTARTEDVortioxetine 10 mg195ClinicalTrials.gov
Overall StudySTARTEDVortioxetine 20 mg207ClinicalTrials.gov
Overall StudyCOMPLETEDPlacebo163ClinicalTrials.gov
Overall StudyCOMPLETEDVortioxetine 10 mg173ClinicalTrials.gov
Overall StudyCOMPLETEDVortioxetine 20 mg178ClinicalTrials.gov
Overall StudyNOT COMPLETEDPlacebo33ClinicalTrials.gov
Overall StudyNOT COMPLETEDVortioxetine 10 mg22ClinicalTrials.gov
Overall StudyNOT COMPLETEDVortioxetine 20 mg29ClinicalTrials.gov

Adverse events 21

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource
otherNauseaGastrointestinal disordersPlacebo8196ClinicalTrials.gov
otherNauseaGastrointestinal disordersVortioxetine 10 mg32195ClinicalTrials.gov
otherNauseaGastrointestinal disordersVortioxetine 20 mg43207ClinicalTrials.gov
otherNasopharyngitisInfections and infestationsPlacebo10196ClinicalTrials.gov
otherNasopharyngitisInfections and infestationsVortioxetine 10 mg7195ClinicalTrials.gov
otherNasopharyngitisInfections and infestationsVortioxetine 20 mg9207ClinicalTrials.gov
otherHeadacheNervous system disordersPlacebo14196ClinicalTrials.gov
otherHeadacheNervous system disordersVortioxetine 10 mg16195ClinicalTrials.gov
otherHeadacheNervous system disordersVortioxetine 20 mg26207ClinicalTrials.gov
seriousHiatus herniaGastrointestinal disordersPlacebo1196ClinicalTrials.gov
seriousHiatus herniaGastrointestinal disordersVortioxetine 10 mg0195ClinicalTrials.gov
seriousHiatus herniaGastrointestinal disordersVortioxetine 20 mg0207ClinicalTrials.gov
seriousCholecystitisHepatobiliary disordersPlacebo1196ClinicalTrials.gov
seriousCholecystitisHepatobiliary disordersVortioxetine 10 mg0195ClinicalTrials.gov
seriousCholecystitisHepatobiliary disordersVortioxetine 20 mg0207ClinicalTrials.gov
seriousType 1 diabetes mellitusMetabolism and nutrition disordersPlacebo0196ClinicalTrials.gov
seriousType 1 diabetes mellitusMetabolism and nutrition disordersVortioxetine 10 mg0195ClinicalTrials.gov
seriousType 1 diabetes mellitusMetabolism and nutrition disordersVortioxetine 20 mg1207ClinicalTrials.gov
seriousHypertensionVascular disordersPlacebo0196ClinicalTrials.gov
seriousHypertensionVascular disordersVortioxetine 10 mg0195ClinicalTrials.gov

Adverse event totals 9

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource
Total, all-cause mortalityPlaceboClinicalTrials.gov
Total, all-cause mortalityVortioxetine 10 mgClinicalTrials.gov
Total, all-cause mortalityVortioxetine 20 mgClinicalTrials.gov
Total, other adverse eventsPlacebo31196ClinicalTrials.gov
Total, other adverse eventsVortioxetine 10 mg48195ClinicalTrials.gov
Total, other adverse eventsVortioxetine 20 mg66207ClinicalTrials.gov
Total, serious adverse eventsPlacebo2196ClinicalTrials.gov
Total, serious adverse eventsVortioxetine 10 mg0195ClinicalTrials.gov
Total, serious adverse eventsVortioxetine 20 mg2207ClinicalTrials.gov

Papers 3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
24787143DERIVEDPubMed
27780334DERIVEDPubMed
33833401DERIVEDPubMed

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 7

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Choice Reaction TimeSecondary outcomeConductCognition
Simple Reaction TimeSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition
Symbol CodingSecondary outcomeConductCognition
Trail Making Test ASecondary outcomeConductCognition
Trail Making Test BSecondary outcomeConductCognition
Verbal LearningSecondary outcomeConductCognition

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

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)