CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 598 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.

Search/NCT01422213
NCT01422213Phase 3Completed

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose Study on the Efficacy of [Vortioxetine] Lu AA21004 on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (MDD)

H. Lundbeck A/S·interventional·Posted Aug 23, 2011·Updated Aug 5, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo and Vortioxetine (Lu AA21004) for Major Depressive Disorder. Completed, enrolled 598 participants.

Detailed Summary

Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD primarily involves mood disturbances, patients also usually present alterations in cognitive function (attention, memory, executive functioning and psychomotor speed). Even though antidepressants are suggested in the literature to potentially improve cognitive dysfunction in patients with MDD to some degree, there is a lack of adequate and well-controlled studies to investigate this effect. This study will evaluate the efficacy, safety and tolerability of a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients with MDD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2011
Enrollment StartDec 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.9 years ago

Interventions

Placebodrug

capsules; daily; orally

Vortioxetine (Lu AA21004)drug

encapsulated tablets; daily; orally

Vortioxetine (Lu AA21004)drug

encapsulated tablets; daily; orally