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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607125
• Other study ID #: 14137A
• Secondary ID: 2011-001839-23
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2012
• Last updated: September 24, 2013
• Start date: July 2012

Study information

• Verified date: September 2013
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Vortioxetine (Lu AA21004)
encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
• Placebo
capsules, orally, once daily for 13 to 14 days

Locations

Country	Name	City	State
United Kingdom	GB001	Headington

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)		Day 1 to Day 13	No
Primary	Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory		Day 1 to Day 13	No
Secondary	Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing		Day 1 to Day 13	No