Trial · NCT01255787

Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

NCT01255787, Phase 2, Phase 3, Completed, Takeda; results first posted 2013-12-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder. Trials, record NCT01255787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01255787

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Trial

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

Title: Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
NCT number: NCT01255787
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 600 participants, actual
Lead sponsor: Takeda
Conditions: Depressive Disorder, Major
Interventions: Vortioxetine, Placebo
First posted: 2010-12-07
Last updated: 2013-12-18
Other registries' IDs: eudract:2010-022257-41
Results first posted: 2013-12-18

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Baseline and Week 8	The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.
Secondary	Percentage of Participants With a MADRS Response at Week 8	Baseline and Week 8	Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Secondary	Percentage of Participants in MADRS Remission at Week 8	Week 8	Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Secondary	Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8	Week 8	The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate.
Secondary	Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8	Baseline and Week 8	The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Baseline and Week 8	The full analysis set included all randomized participants who received at least 1 dose of study drug. One patient in the placebo arm was excluded from all datasets due to enrollment in another clinical study. Only participants with Baseline and at least 1 post-baseline value are included. Last observation carried forward (LOCF) was used.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With a MADRS Response at Week 8	Baseline and Week 8	Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants in MADRS Remission at Week 8	Week 8	Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.	percentage of participants	NUMBER
SECONDARY	Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8	Week 8	Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8	Baseline and Week 8	Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.	scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Placebo	-13.99	Standard Error 0.783	scores on a scale
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Vortioxetine 5 mg	-14.61	Standard Error 0.805	scores on a scale
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Vortioxetine 10 mg	-15.68	Standard Error 0.791	scores on a scale
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Vortioxetine 20 mg	-15.82	Standard Error 0.786	scores on a scale
Percentage of Participants With a MADRS Response at Week 8	Placebo	39.3		percentage of participants
Percentage of Participants With a MADRS Response at Week 8	Vortioxetine 5 mg	49.3		percentage of participants
Percentage of Participants With a MADRS Response at Week 8	Vortioxetine 10 mg	54.4		percentage of participants
Percentage of Participants With a MADRS Response at Week 8	Vortioxetine 20 mg	51.0		percentage of participants
Percentage of Participants in MADRS Remission at Week 8	Placebo	26.7		percentage of participants
Percentage of Participants in MADRS Remission at Week 8	Vortioxetine 5 mg	24.6		percentage of participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow16

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	152
Overall Study	STARTED	Vortioxetine 5 mg	144
Overall Study	STARTED	Vortioxetine 10 mg	150
Overall Study	STARTED	Vortioxetine 20 mg	154
Overall Study	Treated	Placebo	152
Overall Study	Treated	Vortioxetine 5 mg	144
Overall Study	Treated	Vortioxetine 10 mg	148
Overall Study	Treated	Vortioxetine 20 mg	150
Overall Study	COMPLETED	Placebo	136
Overall Study	COMPLETED	Vortioxetine 5 mg	127

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events180

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
other	Palpitations	Cardiac disorders	Placebo	2	151
other	Palpitations	Cardiac disorders	Vortioxetine 5 mg	0	144
other	Palpitations	Cardiac disorders	Vortioxetine 10 mg	0	148
other	Palpitations	Cardiac disorders	Vortioxetine 20 mg	3	150
other	Tinnitus	Ear and labyrinth disorders	Placebo	3	151
other	Tinnitus	Ear and labyrinth disorders	Vortioxetine 5 mg	2	144
other	Tinnitus	Ear and labyrinth disorders	Vortioxetine 10 mg	1	148
other	Tinnitus	Ear and labyrinth disorders	Vortioxetine 20 mg	3	150
other	Vertigo	Ear and labyrinth disorders	Placebo	3	151
other	Vertigo	Ear and labyrinth disorders	Vortioxetine 5 mg	1	144

1 to 10 of 180Source ClinicalTrials.gov

See all 180 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Vortioxetine 5 mg
Total, all-cause mortality	Vortioxetine 10 mg
Total, all-cause mortality	Vortioxetine 20 mg
Total, other adverse events	Placebo	97	151
Total, other adverse events	Vortioxetine 5 mg	96	144
Total, other adverse events	Vortioxetine 10 mg	93	148
Total, other adverse events	Vortioxetine 20 mg	106	150
Total, serious adverse events	Placebo	1	151
Total, serious adverse events	Vortioxetine 5 mg	2	144

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28858412	DERIVED	PubMed
36708956	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons0

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

None in this release.

Tests0

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

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01255787

GET https://conductscience.org/api/trials/v1/NCT01255787/events?page=2

API reference For AI assistants