NCT03272711

Brief Summary

The purpose of this research study is to examine the potential benefits of vortioxetine in combination with at-home computerized cognitive training program to improve cognition, such as memory, attention, and concentration. This study will compare the effectiveness of vortioxetine plus cognitive training versus placebo plus cognitive training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 14, 2020

Completed
Last Updated

January 14, 2020

Status Verified

December 1, 2019

Enrollment Period

2.4 years

First QC Date

September 1, 2017

Results QC Date

December 2, 2019

Last Update Submit

December 27, 2019

Conditions

Age-related Cognitive Decline

Keywords

VortioxetineElderlyOnline cognitive training

Outcome Measures

Primary Outcomes (1)

  • Change in Total Fluid Cognitive Score

    Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured "fluid" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.

    Randomization (0 weeks), 4 weeks

Secondary Outcomes (2)

  • Change in Total Fluid Cognitive Score

    Randomization (0 weeks), 4 week, 12 week, 26 week

  • Participant Function

    Randomization (0 weeks), 26 weeks

Study Arms (2)

Vortioxetine plus cognitive training

EXPERIMENTAL

Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day

Drug: Vortioxetine 10 mgBehavioral: Cognitive training program

Placebo plus cognitive training

PLACEBO COMPARATOR

Placebo plus cognitive training 5 times weekly for 30 minutes a day

Behavioral: Cognitive training program

Interventions

Vortioxetine 10 mgDRUG
Also known as: Trintellix
Vortioxetine plus cognitive training
Cognitive training programBEHAVIORAL

Online training program, 30 minutes a day, 5 times a week

Placebo plus cognitive trainingVortioxetine plus cognitive training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-living men and women age 65 and older
  • Age-related cognitive decline as defined by (a) self-reported cognitive dysfunction that is attributed to the aging process (in response to screening questions to the participant); (b) ability to complete cognitive battery, but still scoring less than 1 standard deviation above age-matched norms at both baseline and after the two-week cognitive training lead-in.

You may not qualify if:

  • Known dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease) per self-report, informant report, medical records, or neuropsychological testing
  • Any current psychiatric disorder
  • Medical conditions that suggest shortened lifespan, such as metastatic cancer; or would prohibit safe participation in the interventions, including cardiovascular disease or musculoskeletal conditions; or with the assessments.
  • Sensory impairment that would prevent participation
  • IQ \< 70 as estimated by the Wechsler Test of Adult Reading
  • Alcohol or substance abuse within 6 months
  • Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity
  • Psychotropic medications or those with likely CNS effects (none within 4 weeks prior to study entry)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

  • Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.

    PMID: 12425704BACKGROUND

  • Bowie CR, Gupta M, Holshausen K, Jokic R, Best M, Milev R. Cognitive remediation for treatment-resistant depression: effects on cognition and functioning and the role of online homework. J Nerv Ment Dis. 2013 Aug;201(8):680-5. doi: 10.1097/NMD.0b013e31829c5030.

    PMID: 23896849BACKGROUND

  • Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer's disease. N Engl J Med. 2013 Mar 28;368(13):1169-71. doi: 10.1056/NEJMp1302513. Epub 2013 Mar 13. No abstract available.

    PMID: 23484795BACKGROUND

  • Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.

    PMID: 25405755BACKGROUND

  • Lenze EJ, Stevens A, Waring JD, Pham VT, Haddad R, Shimony J, Miller JP, Bowie CR. Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial. Am J Psychiatry. 2020 Jun 1;177(6):548-555. doi: 10.1176/appi.ajp.2019.19050561. Epub 2020 Mar 26.

    PMID: 32212856DERIVED

MeSH Terms

Interventions

Vortioxetine

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Eric Lenze
Organization
Washington University School of Medicine
lenzee@wustl.edu
314-362-1671

Study Officials

  • Eric Lenze, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 5, 2017

Study Start

August 31, 2016

Primary Completion

January 24, 2019

Study Completion

January 24, 2019

Last Updated

January 14, 2020

Results First Posted

January 14, 2020

Record last verified: 2019-12

Locations

US(1)