At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 457 enrolled
Drug / intervention
Vortioxetine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
In Brief
A Phase 3 clinical trial evaluating Vortioxetine and Placebo for Generalized Anxiety Disorder. Completed, enrolled 457 participants across 40 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Anxiety Disorder
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedAug 2008
Primary CompletionJan 2009
Study CompletionFeb 2009
TodayJul 2026
First PostedAug 8, 2008
Enrollment StartJun 1, 2008
Primary CompletionJan 1, 2009
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.9 years ago
Interventions
Vortioxetinedrug
Encapsulated vortioxetine immediate-release tablets
Placebodrug
Vortioxetine placebo-matching capsules