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Major Depressive DisorderPhase 4AtWoRCNCT02332954

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

A Phase 4 study testing vortioxetine in people with Major Depressive Disorder, run by Lundbeck Canada Inc. at 26 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
vortioxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
26 sitesCanada
Study dates
Feb 2015to 6 Jul 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Canada26 sites

  • CA016

    Burlington, Ontario, L7R 4E2

  • CA013

    Chatham, Ontario, N7L 1C1

  • CA010

    Corunna, Ontario, N0N 1G0

  • CA004

    Edmonton, Alberta, T6L 6W6

  • CA012

    Fort Erie, Ontario, L2A 1Z3

  • CA007

    Halifax, Nova Scotia, B3S 1M7

  • CA017

    Hamilton, Ontario, L8M 1K7

  • CA026

    Hamilton, Ontario, L8N 4A6

  • CA005

    Kelowna, British Columbia, V1Y 1Z9

  • CA011

    London, Ontario, N6H 4P2

  • CA003

    Mississauga, Ontario, L5M 4N4

  • CA022

    Montreal, Quebec, H1N 3V2

  • CA020

    Montreal, Quebec, H2R 1V6

  • CA023

    Montreal, Quebec, H3A 0G6

  • CA018

    Pointe-Claire, Quebec, H9R 4S3

  • CA019

    Québec, G1G 3Y8

  • CA021

    Québec, G3K 2P8

  • CA029

    Québec, G3K 2P8

  • CA024

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

  • CA008

    Sarnia, Ontario, N7T 4X3

  • CA009

    Sarnia, Ontario, N7T 4X3

  • CA028

    Saskatoon, Saskatchewan, S7K 3H3

  • CA015

    St. Catharines, Ontario, L2T 3Y4

  • CA006

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

  • CA030

    Victoriaville, Quebec, G6P 6P6

  • CA027

    Westmount, Quebec, H4A1S9

Other trials in Canada

About this study

Official title: 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).

Read the 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.

Being tested
vortioxetine
Keywords
Depression, Major Depressive Disorder, Cognition, Cognitive symptoms, vortioxetine, real life, naturalistic
Medical subject headings
Depressive Disorder, Major, Depression, Neurobehavioral Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vortioxetineDrug

    Also called Trintellix

    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.

Study groups in NCT02332954
Study groupRoleWhat they receive
vortioxetine naiveOthervortioxetine 10 mg 100 patients with Major Depressive Disorder who have not been treated with another antidepressant for the current MDE
Receives: Drug: vortioxetine
SwitchOthervortioxetine 10 mg 100 patients with Major Depressive Disorder that require a switch from their current antidepressant due to inadequate response
Receives: Drug: vortioxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 weeks

Secondary outcomes (9)

  1. Cognitive function (PDQ-D-20)

    Mean change from baseline in cognitive symptoms as measured by PDQ-D-20.

    Measured: 12 and 52 weeks

  2. Cognitive function (Digit Symbol Substitution Test (DSST)

    Mean change from baseline in cognitive symptoms as measured by Digit Symbol Substitution Test (DSST).

    Measured: 12 and 52 weeks

  3. Work productivity (WLQ)

    mean change from baseline in work productivity as measured by WLQ.

    Measured: 12 and 52 weeks

  4. Work productivity (Work Productivity and Activity Impairment (WPAI) questionnaire)

    mean change from baseline in work productivity as measured by Work Productivity and Activity Impairment (WPAI) questionnaire.

    Measured: 12 and 52 weeks

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

    mean change from baseline in work productivity as measured by World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12).

    Measured: 12 and 52 weeks

  6. Work productivity (Sheehan Disability Scale (SDS)

    mean change from baseline in work productivity as measured by Sheehan Disability Scale (SDS).

    Measured: 12 and 52 weeks

  7. Depressive symptoms (Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR)

    mean change from baseline in depressive symptoms as measured by Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR).

    Measured: 12 and 52 weeks

  8. Depressive symptoms (Clinical Global Impression-Improvement (CGI-I) score)

    mean change in depressive symptoms as measured by Clinical Global Impression-Improvement (CGI-I) score.

    Measured: 12 and 52 weeks

  9. Depressive symptoms (Clinical Global Impression-Severity (CGI-S)

    mean change from baseline in depressive symptoms as measured by Clinical Global Impression-Severity (CGI-S).

    Measured: 12 and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion6 Jul 2017
  4. Study completion6 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02332954
Sponsor's protocol ID
15913A
Acronym
AtWoRC
Status last verified
Jan 2018
First submitted
5 Jan 2015
Last updated
30 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30802419

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing vortioxetine in people with Major Depressive Disorder, run by Lundbeck Canada Inc. at 26 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the association/correlation between changes in patient-reported cognitive symptoms and work productivity. (Perceived Deficit Questionnaire-Depression) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02332954, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.

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