At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 781 enrolled
Drug / intervention
Placebo +2 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, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
In Brief
A Phase 3 clinical trial evaluating Placebo, Vortioxetine, and 1 other intervention for Generalized Anxiety Disorder. Completed, enrolled 781 participants across 66 sites.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of 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 CompletionFeb 2009
TodayJul 2026
First PostedAug 8, 2008
Enrollment StartJun 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.9 years ago
Interventions
Placebodrug
Placebo-matching capsules
Vortioxetinedrug
Encapsulated vortioxetine immediate release tablets
Duloxetinedrug
Overencapsulated duloxetine capsules