Trial · NCT00672958
Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder
NCT00672958, Phase 3, Completed, Takeda; results first posted 2013-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder. Trials, record NCT00672958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00672958
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder
- NCT number
- NCT00672958
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 600 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Major Depressive Disorder
- Interventions
- Vortioxetine, Placebo
- First posted
- 2008-05-06
- Last updated
- 2013-12-13
- Results first posted
- 2013-12-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6 | Baseline and Week 6 | The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. 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. |
| Primary | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Baseline and Weeks 1, 2, 3, 4 and 5 | The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. 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-D24 Total Score by Study Visit | Baseline and Weeks 1, 2, 3, 4, 5 and 6. | A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. |
| Secondary | Percentage of Participants in MADRS Remission at Week 6 | Week 6 | 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 | Percentage of Participants With a Sustained Response in HAM-D24 | Baseline to Week 6 | A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 5 and at least 50% decrease from Baseline at Week 6. |
| Secondary | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | Baseline and Weeks 1, 2, 3, 4, 5 and 6. | 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). A decrease in the total score or on individual items indicates improvement. Least square means are from an 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) | 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. Least squares means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. |
| Secondary | Change From Baseline in Clinical Global Impression Scale-Severity of Illness | Baseline and Weeks 1, 2, 3, 4, 5 and 6. | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient'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 with treatment and center as fixed factors and the Baseline value as a covariate. |
| Secondary | Clinical Global Impression Scale-Global Improvement Scale | Baseline and Weeks 1, 2, 3, 4, 5 and 6. | 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 and center as fixed factors and the CGI-S Baseline value as a covariate. |
| Secondary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) | Baseline and Weeks 1, 4 and 6. | The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 24-item Hamilton Depression Scale Total Score at Week 6 | Baseline and Week 6 | The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used. | scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Baseline and Weeks 1, 2, 3, 4 and 5 | 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-D24 Total Score by Study Visit | Baseline and Weeks 1, 2, 3, 4, 5 and 6. | Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in MADRS Remission at Week 6 | Week 6 | Full analysis set; LOCF was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Sustained Response in HAM-D24 | Baseline to Week 6 | Full analysis set. Participants with missing values were classified as nonsustained responders/remitters. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | Baseline and Weeks 1, 2, 3, 4, 5 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 | Change From Baseline in Hamilton Anxiety Scale (HAM-A) | 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 | Change From Baseline in Clinical Global Impression Scale-Severity of Illness | Baseline and Weeks 1, 2, 3, 4, 5 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 | Clinical Global Impression Scale-Global Improvement Scale | Baseline and Weeks 1, 2, 3, 4, 5 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 | Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) | Baseline and Weeks 1, 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group116
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 24-item Hamilton Depression Scale Total Score at Week 6 | Placebo | -13.87 | Standard Error 0.662 | scores on a scale | |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6 | Vortioxetine | -14.61 | Standard Error 0.650 | scores on a scale | |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Placebo | Week 1 (n=281, 286) | -6.03 | Standard Error 0.394 | scores on a scale |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Vortioxetine | Week 1 (n=281, 286) | -5.96 | Standard Error 0.387 | scores on a scale |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Placebo | Week 2 (n= 286, 291) | -9.30 | Standard Error 0.505 | scores on a scale |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Vortioxetine | Week 2 (n= 286, 291) | -9.05 | Standard Error 0.496 | scores on a scale |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Placebo | Week 3 (n= 286, 292) | -11.05 | Standard Error 0.545 | scores on a scale |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Vortioxetine | Week 3 (n= 286, 292) | -11.73 | Standard Error 0.536 | scores on a scale |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Placebo | Week 4 (n= 286, 292) | -12.33 | Standard Error 0.579 | scores on a scale |
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | Vortioxetine | Week 4 (n= 286, 292) | -12.66 | Standard Error 0.568 | scores on a scale |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 300 | |
| Overall Study | STARTED | Vortioxetine | 300 | |
| Overall Study | Safety Set | Placebo | 298 | |
| Overall Study | Safety Set | Vortioxetine | 299 | |
| Overall Study | Full Analysis Set | Placebo | 286 | |
| Overall Study | Full Analysis Set | Vortioxetine | 292 | |
| Overall Study | COMPLETED | Placebo | 236 | |
| Overall Study | COMPLETED | Vortioxetine | 244 | |
| Overall Study | NOT COMPLETED | Placebo | 64 | |
| Overall Study | NOT COMPLETED | Vortioxetine | 56 |
Source ClinicalTrials.gov
Adverse events64
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 | Nausea | Gastrointestinal disorders | Placebo | 28 | 298 | |
| other | Nausea | Gastrointestinal disorders | Vortioxetine | 57 | 299 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 21 | 298 | |
| other | Diarrhoea | Gastrointestinal disorders | Vortioxetine | 34 | 299 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 19 | 298 | |
| other | Dry mouth | Gastrointestinal disorders | Vortioxetine | 25 | 299 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 298 | |
| other | Abdominal pain | Gastrointestinal disorders | Vortioxetine | 12 | 299 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 10 | 298 | |
| other | Dyspepsia | Gastrointestinal disorders | Vortioxetine | 5 | 299 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Vortioxetine | ||
| Total, other adverse events | Placebo | 142 | 298 |
| Total, other adverse events | Vortioxetine | 168 | 299 |
| Total, serious adverse events | Placebo | 4 | 298 |
| Total, serious adverse events | Vortioxetine | 7 | 299 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22963932 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vortioxetine vs Placebo: serious adverse events |
Source Trial comparisons
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT00672958/results?page=2