CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 493 enrolled
Drug / intervention
Placebo +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.

Search/NCT02389816
NCT02389816Phase 3Completed
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Once Daily Oral Lu AA21004 in Patients With Major Depressive Disorder

Takeda·interventional·Posted Mar 17, 2015·Updated Mar 24, 2021

In Brief

A Phase 3 clinical trial evaluating Placebo and Vortioxetine for Major Depressive Disorder. Completed, enrolled 493 participants across 47 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy of two fixed doses of vortioxetine (Lu AA21004; 10 or 20 mg/day) after 8 weeks of treatment in patients with major depressive disorder (MDD) in Japan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 17, 2015
Enrollment StartApr 10, 2015
Primary CompletionMar 16, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.3 years ago

Interventions

Placebodrug

Placebo tablets

Vortioxetinedrug

Vortioxetine tablets