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.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01607125
First received: May 24, 2012
Last updated: September 24, 2013
Last verified: September 2013

May 24, 2012
September 24, 2013
July 2012
September 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Effect of Lu AA21004 on BOLD signal in fMRI of the brain areas associated with executive function (working memory) [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Effect of Lu AA21004 on BOLD signal in fMRI of the brain areas associated with spatial memory [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01607125 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Effect of Lu AA21004 on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Depression
  • Drug: Vortioxetine (Lu AA21004)
    encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
    Other Name: Brintellix
  • Drug: Placebo
    capsules, orally, once daily for 13 to 14 days
  • Experimental: Vortioxetine
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
Not Provided
September 2013   (final data collection date for primary outcome measure)

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.

Both
25 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01607125
14137A, 2011-001839-23
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP