NCT02332954

Brief Summary

The purpose of the study is to describe the association/correlation between change in patient-reported cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a Major Depressive Episode (MDE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

26 active sites

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

First Submitted

Initial submission to the registry

January 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

January 5, 2015

Last Update Submit

January 26, 2018

Conditions

Major Depressive Disorder

Keywords

DepressionMajor Depressive DisorderCognitionCognitive symptomsvortioxetinereal lifenaturalistic

Outcome Measures

Primary Outcomes (1)

  • the association/correlation between changes in patient-reported cognitive symptoms and work productivity. (Perceived Deficit Questionnaire-Depression)

    Mean change from Baseline to Week 12 in patient-reported cognitive symptoms as measured by Perceived Deficit Questionnaire-Depression-20 questions (PDQ-D-20) and work productivity as measured by Work Limitations Questionnaire (WLQ) in gainfully employed patients receiving vortioxetine for a Major Depressive Episode (MDE).

    12 weeks

Secondary Outcomes (9)

  • Cognitive function (PDQ-D-20)

    12 and 52 weeks

  • Cognitive function (Digit Symbol Substitution Test (DSST)

    12 and 52 weeks

  • Work productivity (WLQ)

    12 and 52 weeks

  • Work productivity (Work Productivity and Activity Impairment (WPAI) questionnaire)

    12 and 52 weeks

  • Work productivity (World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12)

    12 and 52 weeks

  • +4 more secondary outcomes

Study Arms (2)

vortioxetine naive

OTHER

vortioxetine 10 mg 100 patients with Major Depressive Disorder who have not been treated with another antidepressant for the current MDE

Drug: vortioxetine

Switch

OTHER

vortioxetine 10 mg 100 patients with Major Depressive Disorder that require a switch from their current antidepressant due to inadequate response

Drug: vortioxetine

Interventions

vortioxetineDRUG

The starting and recommended dose of vortioxetine is 10 mg once daily; film-coated 10 mg tablets for oral use once daily for 52 weeks.Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.

Also known as: Trintellix
Switchvortioxetine naive

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is a man or woman, aged ≥18 years and \<65 years (In the province of British Columbia, the patient must be aged 19 years or older in order to give Informed Consent)
  • The patient is engaged in volunteer work or gainful employment (working ≥20 hours per week) or is enrolled full-time in post-secondary studies or vocational training.
  • The patient is an outpatient consulting a Primary Care Physician or a Psychiatrist.
  • Patients must have a diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™) classification code 296.3x.
  • The current MDE is confirmed by the investigator.
  • The reported duration of the current MDE is at least 3 months.
  • The patient has a Baseline score ≥15 on the QIDS-SR.
  • The patient reports at least a minimal level of cognitive symptoms as defined by Baseline score of ≥30 on the PDQ-D-20.
  • The patient is capable of communicating with the site personnel and is able to conduct the digit-symbol substitution test (DSST).

You may not qualify if:

  • The patient score is \>69 on the DSST at Screening/Baseline.
  • The patient is, in the opinion of the investigator, not able to complete all the study assessments including, but not limited to, patient-reported assessments and the DSST.
  • The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features.
  • The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the maximum recommended dose (according to Canadian labeling).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

CA004

Edmonton, Alberta, T6L 6W6, Canada

Location

CA005

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

CA006

St. John's, Newfoundland and Labrador, A1E 2C2, Canada

Location

CA007

Halifax, Nova Scotia, B3S 1M7, Canada

Location

CA016

Burlington, Ontario, L7R 4E2, Canada

Location

CA013

Chatham, Ontario, N7L 1C1, Canada

Location

CA010

Corunna, Ontario, N0N 1G0, Canada

Location

CA012

Fort Erie, Ontario, L2A 1Z3, Canada

Location

CA017

Hamilton, Ontario, L8M 1K7, Canada

Location

CA026

Hamilton, Ontario, L8N 4A6, Canada

Location

CA011

London, Ontario, N6H 4P2, Canada

Location

CA003

Mississauga, Ontario, L5M 4N4, Canada

Location

CA008

Sarnia, Ontario, N7T 4X3, Canada

Location

CA009

Sarnia, Ontario, N7T 4X3, Canada

Location

CA015

St. Catharines, Ontario, L2T 3Y4, Canada

Location

CA022

Montreal, Quebec, H1N 3V2, Canada

Location

CA020

Montreal, Quebec, H2R 1V6, Canada

Location

CA023

Montreal, Quebec, H3A 0G6, Canada

Location

CA018

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

CA024

Saint-Jean-sur-Richelieu, Quebec, J2W 1J1, Canada

Location

CA030

Victoriaville, Quebec, G6P 6P6, Canada

Location

CA027

Westmount, Quebec, H4A1S9, Canada

Location

CA028

Saskatoon, Saskatchewan, S7K 3H3, Canada

Location

CA019

Québec, G1G 3Y8, Canada

Location

CA021

Québec, G3K 2P8, Canada

Location

CA029

Québec, G3K 2P8, Canada

Location

Related Publications (1)

  • Chokka P, Bougie J, Proulx J, Tvistholm AH, Ettrup A. Long-term functioning outcomes are predicted by cognitive symptoms in working patients with major depressive disorder treated with vortioxetine: results from the AtWoRC study. CNS Spectr. 2019 Dec;24(6):616-627. doi: 10.1017/S1092852919000786.

    PMID: 30802419DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepressionNeurobehavioral Manifestations

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehaviorNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pratap Chokka, M.D.

    Chokka Center for Integrative Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 7, 2015

Study Start

February 1, 2015

Primary Completion

July 6, 2017

Study Completion

July 6, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

CA(26)