Trial · NCT00730691

Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

NCT00730691, Phase 3, Completed, Takeda; results first posted 2013-12-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder. Trials, record NCT00730691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730691

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Trial

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

Title: Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
NCT number: NCT00730691
Status: Completed
Phases: Phase 3
Enrollment: 781 participants, actual
Lead sponsor: Takeda
Conditions: Generalized Anxiety Disorder
Interventions: Placebo, Vortioxetine, Duloxetine
First posted: 2008-08-08
Last updated: 2013-12-18
Results first posted: 2013-12-18

Source ClinicalTrials.gov

Registered outcomes16

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8	Baseline to Week 8	The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Secondary	Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8	Baseline to Week 8	The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Secondary	Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8	Baseline to Week 8	The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator 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 a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Secondary	Change From Baseline in Sheehan Disability Scale (SDS) at Week 8	Baseline to Week 8	The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family 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 a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Secondary	Percentage of Responders in HAM-A Total Score at Week 8	Week 8	Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 (symptoms absent) to 56 (maximum severity).
Secondary	Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25	Baseline to Week 8	The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Secondary	Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed	Baseline to Weeks 1, 2, 4 and 6	The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Secondary	Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed	Baseline to Weeks 1 and 4	The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Secondary	Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed	Baseline to Weeks 1, 2, 4 and 6	The Clinical Global Impression - Global Improvement scale measures 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 a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Secondary	Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed	Baseline to Weeks 1, 2 and 4	The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family 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 a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

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 the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8	Baseline to Week 8	The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8	Baseline to Week 8	Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8	Baseline to Week 8	Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sheehan Disability Scale (SDS) at Week 8	Baseline to Week 8	Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Responders in HAM-A Total Score at Week 8	Week 8	Full analysis set; Last observation carried forward (LOCF) was used.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25	Baseline to Week 8	Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed	Baseline to Weeks 1, 2, 4 and 6	Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed	Baseline to Weeks 1 and 4	Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed	Baseline to Weeks 1, 2, 4 and 6	Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed	Baseline to Weeks 1, 2 and 4	Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point.	scores on a scale	LEAST_SQUARES_MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group250

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

Outcome	Group	Value	Spread	Units
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8	Placebo	-11.27	Standard Error 0.595	scores on a scale
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8	Vortioxetine 2.5 mg	-12.23	Standard Error 0.600	scores on a scale
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8	Vortioxetine 5 mg	-11.57	Standard Error 0.606	scores on a scale
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8	Vortioxetine 10 mg	-11.66	Standard Error 0.606	scores on a scale
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8	Duloxetine 60 mg	-13.87	Standard Error 0.635	scores on a scale
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8	Placebo	-4.00	Standard Error 0.361	scores on a scale
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8	Vortioxetine 2.5 mg	-3.89	Standard Error 0.364	scores on a scale
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8	Vortioxetine 5 mg	-4.24	Standard Error 0.366	scores on a scale
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8	Vortioxetine 10 mg	-5.09	Standard Error 0.372	scores on a scale
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8	Duloxetine 60 mg	-5.54	Standard Error 0.385	scores on a scale

1 to 10 of 250Source ClinicalTrials.gov

See all 250 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	157
Overall Study	STARTED	Vortioxetine 2.5 mg	156
Overall Study	STARTED	Vortioxetine 5 mg	156
Overall Study	STARTED	Vortioxetine 10 mg	156
Overall Study	STARTED	Duloxetine 60 mg	156
Overall Study	COMPLETED	Placebo	121
Overall Study	COMPLETED	Vortioxetine 2.5 mg	120
Overall Study	COMPLETED	Vortioxetine 5 mg	117
Overall Study	COMPLETED	Vortioxetine 10 mg	111
Overall Study	COMPLETED	Duloxetine 60 mg	106

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events195

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	Vision blurred	Eye disorders	Placebo	6	155
other	Vision blurred	Eye disorders	Vortioxetine 2.5 mg	2	156
other	Vision blurred	Eye disorders	Vortioxetine 5 mg	1	155
other	Vision blurred	Eye disorders	Vortioxetine 10 mg	4	156
other	Vision blurred	Eye disorders	Duloxetine 60 mg	4	154
other	Nausea	Gastrointestinal disorders	Placebo	27	155
other	Nausea	Gastrointestinal disorders	Vortioxetine 2.5 mg	26	156
other	Nausea	Gastrointestinal disorders	Vortioxetine 5 mg	45	155
other	Nausea	Gastrointestinal disorders	Vortioxetine 10 mg	53	156
other	Nausea	Gastrointestinal disorders	Duloxetine 60 mg	57	154

1 to 10 of 195Source ClinicalTrials.gov

See all 195 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Vortioxetine 2.5 mg
Total, all-cause mortality	Vortioxetine 5 mg
Total, all-cause mortality	Vortioxetine 10 mg
Total, all-cause mortality	Duloxetine 60 mg
Total, other adverse events	Placebo	85	155
Total, other adverse events	Vortioxetine 2.5 mg	100	156
Total, other adverse events	Vortioxetine 5 mg	104	155
Total, other adverse events	Vortioxetine 10 mg	111	156
Total, other adverse events	Duloxetine 60 mg	116	154

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24341301	DERIVED

Source 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.

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