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 | Completed Phase 1

• 2 other identifiers: 14137A2011-001839-23
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing

  Day 1 to Day 13

Study Arms (2)

Vortioxetine

EXPERIMENTAL

Drug: Vortioxetine (Lu AA21004)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Vortioxetine (Lu AA21004) DRUG

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

Also known as: Brintellix

Vortioxetine

Placebo DRUG

capsules, orally, once daily for 13 to 14 days

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

GB001

Headington, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Depression

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2013
• Last Updated: September 25, 2013

Record last verified: 2013-09

Locations

GB (1)