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
Primary Purpose
Depression
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Vortioxetine (Lu AA21004)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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.
Sites / Locations
- GB001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vortioxetine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)
Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory
Secondary Outcome Measures
Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01607125
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vortioxetine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vortioxetine (Lu AA21004)
Other Intervention Name(s)
Brintellix
Intervention Description
encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsules, orally, once daily for 13 to 14 days
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
GB001
City
Headington
ZIP/Postal Code
OX3 7JX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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