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

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Vortioxetine (Lu AA21004); Drug: Placebo

• Registration Number: NCT01607125
• Lead Sponsor: H. Lundbeck A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Study Start: 2012-07
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vortioxetine	Vortioxetine (Lu AA21004)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)	Day 1 to Day 13
Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory	Day 1 to Day 13

Secondary Outcome Measures

Name	Time	Method
Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing	Day 1 to Day 13

Trial Locations

Locations (1)

GB001; 🇬🇧 Headington, United Kingdom