Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine (AtWoRC)

January 26, 2018 updated by: Lundbeck Canada Inc.

Interventional, Open-Label, Single Cohort, Canadian Study to Describe the Relationship Between Cognitive Symptoms and Work Productivity in Working Adults Treated With Vortioxetine for Major Depressive Disorder (MDD)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an interventional, Canadian, multi-site, open-label, single cohort, flexible-dose study. The study will emulate a naturalistic real-life setting. Investigators will include Primary Care Physicians and Psychiatrists working in outpatient clinics. The study will include adult patients diagnosed with MDD according to the DSM-5™. Approximately 200 patients will be enrolled in the study. There will be approximately 100 patients who receive vortioxetine as a first treatment for the current MDE and 100 patients switched to vortioxetine due to inadequate response to their current antidepressant medication treatment. All patients will be treated with vortioxetine as per the product monograph, and at the doses determined appropriate by the investigator. The total study duration from Baseline to the end of follow-up will be approximately 56 weeks.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1G 3Y8
        • CA019
      • Quebec, Canada, G3K 2P8
        • CA021
      • Quebec, Canada, G3K 2P8
        • CA029
    • Alberta
      • Edmonton, Alberta, Canada, T6L 6W6
        • CA004
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • CA005
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 2C2
        • CA006
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1M7
        • CA007
    • Ontario
      • Burlington, Ontario, Canada, L7R 4E2
        • CA016
      • Chatham, Ontario, Canada, N7L 1C1
        • CA013
      • Corunna, Ontario, Canada, N0N 1G0
        • CA010
      • Fort Erie, Ontario, Canada, L2A 1Z3
        • CA012
      • Hamilton, Ontario, Canada, L8M 1K7
        • CA017
      • Hamilton, Ontario, Canada, L8N 4A6
        • CA026
      • London, Ontario, Canada, N6H 4P2
        • CA011
      • Mississauga, Ontario, Canada, L5M 4N4
        • CA003
      • Sarnia, Ontario, Canada, N7T 4X3
        • CA008
      • Sarnia, Ontario, Canada, N7T 4X3
        • CA009
      • St. Catharines, Ontario, Canada, L2T 3Y4
        • CA015
    • Quebec
      • Montreal, Quebec, Canada, H1N 3V2
        • CA022
      • Montreal, Quebec, Canada, H2R 1V6
        • CA020
      • Montreal, Quebec, Canada, H3A 0G6
        • CA023
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • CA018
      • St-Jean-sur-Richelieu, Quebec, Canada, J2W 1J1
        • CA024
      • Victoriaville, Quebec, Canada, G6P 6P6
        • CA030
      • Westmount, Quebec, Canada, H4A1S9
        • CA027
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • CA028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Other protocol defined inclusion and exclusion criteria do apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: vortioxetine naive
vortioxetine 10 mg 100 patients with Major Depressive Disorder who have not been treated with another antidepressant for the current MDE
Drug: vortioxetine
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.
Other Names:
  • Trintellix
OTHER: Switch
vortioxetine 10 mg 100 patients with Major Depressive Disorder that require a switch from their current antidepressant due to inadequate response
Drug: vortioxetine
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.
Other Names:
  • Trintellix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the association/correlation between changes in patient-reported cognitive symptoms and work productivity. (Perceived Deficit Questionnaire-Depression)
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function (PDQ-D-20)
Time Frame: 12 and 52 weeks
Mean change from baseline in cognitive symptoms as measured by PDQ-D-20.
12 and 52 weeks
Cognitive function (Digit Symbol Substitution Test (DSST)
Time Frame: 12 and 52 weeks
Mean change from baseline in cognitive symptoms as measured by Digit Symbol Substitution Test (DSST).
12 and 52 weeks
Work productivity (WLQ)
Time Frame: 12 and 52 weeks
mean change from baseline in work productivity as measured by WLQ.
12 and 52 weeks
Work productivity (Work Productivity and Activity Impairment (WPAI) questionnaire)
Time Frame: 12 and 52 weeks
mean change from baseline in work productivity as measured by Work Productivity and Activity Impairment (WPAI) questionnaire.
12 and 52 weeks
Work productivity (World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12)
Time Frame: 12 and 52 weeks
mean change from baseline in work productivity as measured by World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12).
12 and 52 weeks
Work productivity (Sheehan Disability Scale (SDS)
Time Frame: 12 and 52 weeks
mean change from baseline in work productivity as measured by Sheehan Disability Scale (SDS).
12 and 52 weeks
Depressive symptoms (Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR)
Time Frame: 12 and 52 weeks
mean change from baseline in depressive symptoms as measured by Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR).
12 and 52 weeks
Depressive symptoms (Clinical Global Impression-Improvement (CGI-I) score)
Time Frame: 12 and 52 weeks
mean change in depressive symptoms as measured by Clinical Global Impression-Improvement (CGI-I) score.
12 and 52 weeks
Depressive symptoms (Clinical Global Impression-Severity (CGI-S)
Time Frame: 12 and 52 weeks
mean change from baseline in depressive symptoms as measured by Clinical Global Impression-Severity (CGI-S).
12 and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lundbeck Canada Inc.

Investigators

  • Principal Investigator: Pratap Chokka, M.D., Chokka Center for Integrative Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

July 6, 2017

Study Completion (ACTUAL)

July 6, 2017

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (ESTIMATE)

January 7, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15913A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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