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

H. Lundbeck A/S1 site in 1 country96 target enrollmentJuly 2012

ConditionsDepression

InterventionsVortioxetine (Lu AA21004)Placebo

DrugsVortioxetine (Lu AA21004)Placebo

Overview

Phase: Phase 1
Intervention: Vortioxetine (Lu AA21004)
Conditions: Depression
Sponsor: H. Lundbeck A/S
Enrollment: 96
Locations: 1
Primary Endpoint: Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

September 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects must have:
•a Hamilton Depression Rating Scale (HAM-D17) total score ≤ 7
•Subjects remitted from depression must:
•be in remission from recurrent depression having suffered from at least two previous Major Depressive Episodes (MDEs)
•have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE
•report present subjective cognitive dysfunction
•not have been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to screening visit
•Control group subjects must:
•have no history of MDEs
•have no history of MDEs in a biological parent or other first degree relative as reported by the subject

Exclusion Criteria

•The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason
•Other inclusion and exclusion criteria may apply.

Arms & Interventions

Vortioxetine

Intervention: Vortioxetine (Lu AA21004)

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)

Time Frame: Day 1 to Day 13

Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory

Time Frame: Day 1 to Day 13

Secondary Outcomes

Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing(Day 1 to Day 13)