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
NCT01607125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2013-09-25
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.
Conditions
Interventions
- DRUG
-
Vortioxetine (Lu AA21004)
encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
- DRUG
-
capsules, orally, once daily for 13 to 14 days
Sponsors & Collaborators
-
H. Lundbeck A/S
lead INDUSTRY
Principal Investigators
-
Email contact via H. Lundbeck A/S · [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2013-09-30
Countries
- United Kingdom
Study Locations
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