Trial · NCT00731120
Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
NCT00731120, Phase 3, Completed, Takeda; results first posted 2013-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder. Trials, record NCT00731120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00731120
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
- NCT number
- NCT00731120
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 457 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Vortioxetine, Placebo
- First posted
- 2008-08-08
- Last updated
- 2013-12-18
- Results first posted
- 2013-12-18
Source ClinicalTrials.gov
Registered outcomes10
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 Scale (HAM-A) Total Score | Baseline and 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 an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate. |
| Secondary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Baseline and 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 an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. |
| Secondary | Percentage of Responders in HAM-A Total Score at Week 8 | Baseline and Week 8 | Response was defined as a participant 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 | Percentage of Participants in HAM-A Remission at Week 8 | Week 8 | Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. 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 | Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed | Baseline and Weeks 1, 2, 4, 6 and 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 adjusting for Baseline CGI-S score, center, and treatment. |
| Secondary | Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S) | Baseline and Weeks 1, 2, 4, 6 and 8. | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model adjusting for Baseline score, center, and treatment. |
| Secondary | Change From Baseline in Hospital Anxiety and Depression (HAD) Scales | Baseline and Weeks 1, 4 and 8. | The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. |
| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) 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 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 an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. |
| Secondary | Change From Baseline in 36-item Short-form Health Survey (SF-36) | Baseline and Week 8 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means were from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate. |
| Secondary | Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire | Baseline and Week 8 | Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. |
Source ClinicalTrials.gov
Outcomes10
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 Scale (HAM-A) Total Score | Baseline and 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 post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) 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 and Weeks 1, 2, 4 and 6 | Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders in HAM-A Total Score at Week 8 | Baseline and Week 8 | Full analysis set; LOCF was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in HAM-A Remission at Week 8 | Week 8 | Full analysis set; LOCF was used. | percentage of participants | NUMBER |
| SECONDARY | Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed | Baseline and Weeks 1, 2, 4, 6 and 8. | Full analysis set; LOCF 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 Clinical Global Impression Scale-Severity of Illness (CGI-S) | Baseline and Weeks 1, 2, 4, 6 and 8. | Full analysis set; LOCF 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) Scales | Baseline and Weeks 1, 4 and 8. | Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) at Week 8 | Baseline and Week 8 | Full analysis set with available data at Baseline; LOCF was used. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 36-item Short-form Health Survey (SF-36) | Baseline and Week 8 | Full analysis set with a Baseline SF-36 measurement; LOCF was used. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire | Baseline and Week 8 | Full analysis set | participants | NUMBER |
Source ClinicalTrials.gov
Results by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score | Placebo | -9.87 | Standard Error 0.584 | scores on a scale | |
| Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score | Vortioxetine 2.5 mg | -10.75 | Standard Error 0.569 | scores on a scale | |
| Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score | Vortioxetine 10 mg | -10.68 | Standard Error 0.581 | scores on a scale | |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Placebo | Week 1 (n=147, 142, 143) | -5.07 | Standard Error 0.433 | scores on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Vortioxetine 2.5 mg | Week 1 (n=147, 142, 143) | -5.29 | Standard Error 0.423 | scores on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Vortioxetine 10 mg | Week 1 (n=147, 142, 143) | -5.30 | Standard Error 0.433 | scores on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Placebo | Week 2 (n=148, 144, 146) | -7.41 | Standard Error 0.501 | scores on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Vortioxetine 2.5 mg | Week 2 (n=148, 144, 146) | -8.11 | Standard Error 0.488 | scores on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Vortioxetine 10 mg | Week 2 (n=148, 144, 146) | -8.05 | Standard Error 0.499 | scores on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed | Placebo | Week 4 (n=148, 144, 146) | -8.88 | Standard Error 0.566 | scores on a scale |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 153 | |
| Overall Study | STARTED | Vortioxetine 2.5 mg | 152 | |
| Overall Study | STARTED | Vortioxetine 10 mg | 152 | |
| Overall Study | Treated | Placebo | 153 | |
| Overall Study | Treated | Vortioxetine 2.5 mg | 151 | |
| Overall Study | Treated | Vortioxetine 10 mg | 152 | |
| Overall Study | COMPLETED | Placebo | 111 | |
| Overall Study | COMPLETED | Vortioxetine 2.5 mg | 109 | |
| Overall Study | COMPLETED | Vortioxetine 10 mg | 116 | |
| Overall Study | NOT COMPLETED | Placebo | 42 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events69
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 |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Placebo | 1 | 153 | |
| other | Palpitations | Cardiac disorders | Vortioxetine 2.5 mg | 5 | 151 | |
| other | Palpitations | Cardiac disorders | Vortioxetine 10 mg | 0 | 152 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 13 | 153 | |
| other | Nausea | Gastrointestinal disorders | Vortioxetine 2.5 mg | 24 | 151 | |
| other | Nausea | Gastrointestinal disorders | Vortioxetine 10 mg | 37 | 152 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 11 | 153 | |
| other | Diarrhoea | Gastrointestinal disorders | Vortioxetine 2.5 mg | 13 | 151 | |
| other | Diarrhoea | Gastrointestinal disorders | Vortioxetine 10 mg | 17 | 152 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 17 | 153 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
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 10 mg | ||
| Total, other adverse events | Placebo | 70 | 153 |
| Total, other adverse events | Vortioxetine 2.5 mg | 72 | 151 |
| Total, other adverse events | Vortioxetine 10 mg | 83 | 152 |
| Total, serious adverse events | Placebo | 1 | 153 |
| Total, serious adverse events | Vortioxetine 2.5 mg | 2 | 151 |
| Total, serious adverse events | Vortioxetine 10 mg | 1 | 152 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24424707 | 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.
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
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