At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 301 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 a Single Dose 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 301 participants across 38 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Anxiety Disorder
CountriesEstonia, Germany, Latvia, Lithuania, Poland, Romania, Russia, Ukraine
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartSep 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedSep 1, 2008
Enrollment StartSep 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.8 years ago
Interventions
Vortioxetinedrug
Encapsulated vortioxetine immediate-release tablets.
Placebodrug
Vortioxetine placebo-matching capsules