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Completed

NCT Number: 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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GB001

Headington, OX3 7JX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria may apply.

Treatment and study plan

Vortioxetine (Lu AA21004)

Drug

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

Other names: Brintellix

Placebo

Drug

capsules, orally, once daily for 13 to 14 days

Primary outcomes

  1. 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

  2. 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

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

    Time frame: Day 1 to Day 13

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
First posted
May 28, 2012
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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