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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01607125

Enrollment

Registered

2012-05-28

Start date

2012-07-31

Completion date

Unknown

Last updated

2013-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

DRUGVortioxetine (Lu AA21004)

encapsulated 20 mg tablets, orally, once daily for 13 to 14 days

DRUGPlacebo

capsules, orally, once daily for 13 to 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

Yes

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 * not report present subjective cognitive dysfunction * never have been treated with antidepressants or psychotherapy

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

Design outcomes

Primary

Measure	Time frame
Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)	Day 1 to Day 13
Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory	Day 1 to Day 13

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026