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

September 24, 2013 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
capsules, orally, once daily for 13 to 14 days
Experimental: Vortioxetine
Drug: Vortioxetine (Lu AA21004)
encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
Other Names:
  • Brintellix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Day 1 to Day 13

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 to Day 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 25, 2012

First Posted (Estimate)

May 28, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14137A
  • 2011-001839-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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