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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

NCT ID: NCT01607125

Last Updated: 2013-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Brief Summary

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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

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vortioxetine

Group Type EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type DRUG

encapsulated 20 mg tablets, orally, once daily for 13 to 14 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsules, orally, once daily for 13 to 14 days

Interventions

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Vortioxetine (Lu AA21004)

encapsulated 20 mg tablets, orally, once daily for 13 to 14 days

Intervention Type DRUG

Placebo

capsules, orally, once daily for 13 to 14 days

Intervention Type DRUG

Other Intervention Names

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Brintellix

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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GB001

Headington, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2011-001839-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14137A

Identifier Type: -

Identifier Source: org_study_id