NCT01607125

Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Exploratory Study Investigating the Effects of [Vortioxetine] Lu AA21004 on Cognition and BOLD fMRI Signals in Subjects Remitted From Depression and Controls

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with executive functioning and memory during cognitive task performances compared to placebo in subjects remitted from depression and in controls, and to explore if Vortioxetine will lead to improved cognitive performance in the absence of depression.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Vortioxetine (Lu AA21004)	encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
DRUG	Placebo	capsules, orally, once daily for 13 to 14 days

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-09-01
• First posted: 2012-05-28
• Last updated: 2013-09-25

Locations

1 site across 1 country: United Kingdom