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NCT00731120 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 457
- Enrollment target
NCT00731120: Completed Phase 3 study, sponsored by Takeda.
NCT00731120 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 457 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00731120, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 457 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Vortioxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 457 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00731120 record still lists
NCT00731120 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00731120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00731120 about?
NCT00731120 is a clinical study titled "Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder". The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.
What is the current status of trial NCT00731120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 457 participants. The study started on 2008-06. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00731120?
The interventions under investigation include: Placebo (DRUG), Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT00731120?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00731120's enrollment target sits among peer trials
457 827th of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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