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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

This study has been completed.
Information provided by (Responsible Party):
H. Lundbeck A/S Identifier:
First received: May 24, 2012
Last updated: September 24, 2013
Last verified: September 2013
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.

Condition Intervention Phase
Drug: Vortioxetine (Lu AA21004)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 96
Study Start Date: July 2012
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vortioxetine Drug: Vortioxetine (Lu AA21004)
encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
Other Name: Brintellix
Placebo Comparator: Placebo Drug: Placebo
capsules, orally, once daily for 13 to 14 days


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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 exclusion criteria may apply.

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Please refer to this study by its identifier: NCT01607125

United Kingdom
Headington, United Kingdom, OX3 7JX
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S
  More Information

Responsible Party: H. Lundbeck A/S Identifier: NCT01607125     History of Changes
Other Study ID Numbers: 14137A
2011-001839-23 ( EudraCT Number )
Study First Received: May 24, 2012
Last Updated: September 24, 2013

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT3 Receptor Antagonists processed this record on May 25, 2017