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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01607125
First received: May 24, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Vortioxetine (Lu AA21004)
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory) [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: July 2012
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vortioxetine Drug: Vortioxetine (Lu AA21004)
encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
Other Name: Brintellix
Placebo Comparator: Placebo Drug: Placebo
capsules, orally, once daily for 13 to 14 days

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607125

Locations
United Kingdom
GB001
Headington, United Kingdom, OX3 7JX
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01607125     History of Changes
Other Study ID Numbers: 14137A, 2011-001839-23
Study First Received: May 24, 2012
Last Updated: September 24, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Vortioxetine
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Agents
Serotonin Antagonists
Serotonin Receptor Agonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014