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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
vortioxetine
Sponsored by
Lundbeck Canada Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Major Depressive Disorder, Cognition, Cognitive symptoms, vortioxetine, real life, naturalistic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CA004
  • CA005
  • CA006
  • CA007
  • CA016
  • CA013
  • CA010
  • CA012
  • CA017
  • CA026
  • CA011
  • CA003
  • CA008
  • CA009
  • CA015
  • CA022
  • CA020
  • CA023
  • CA018
  • CA024
  • CA030
  • CA027
  • CA028
  • CA019
  • CA021
  • CA029

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

vortioxetine naive

Switch

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cognitive function (PDQ-D-20)
Mean change from baseline in cognitive symptoms as measured by PDQ-D-20.
Cognitive function (Digit Symbol Substitution Test (DSST)
Mean change from baseline in cognitive symptoms as measured by Digit Symbol Substitution Test (DSST).
Work productivity (WLQ)
mean change from baseline in work productivity as measured by WLQ.
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.
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).
Work productivity (Sheehan Disability Scale (SDS)
mean change from baseline in work productivity as measured by Sheehan Disability Scale (SDS).
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).
Depressive symptoms (Clinical Global Impression-Improvement (CGI-I) score)
mean change in depressive symptoms as measured by Clinical Global Impression-Improvement (CGI-I) score.
Depressive symptoms (Clinical Global Impression-Severity (CGI-S)
mean change from baseline in depressive symptoms as measured by Clinical Global Impression-Severity (CGI-S).

Full Information

First Posted
January 5, 2015
Last Updated
January 26, 2018
Sponsor
Lundbeck Canada Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02332954
Brief Title
Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine
Acronym
AtWoRC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundbeck Canada Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Major Depressive Disorder, Cognition, Cognitive symptoms, vortioxetine, real life, naturalistic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vortioxetine naive
Arm Type
Other
Arm Description
vortioxetine 10 mg 100 patients with Major Depressive Disorder who have not been treated with another antidepressant for the current MDE
Arm Title
Switch
Arm Type
Other
Arm Description
vortioxetine 10 mg 100 patients with Major Depressive Disorder that require a switch from their current antidepressant due to inadequate response
Intervention Type
Drug
Intervention Name(s)
vortioxetine
Other Intervention Name(s)
Trintellix
Intervention Description
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.
Primary Outcome Measure Information:
Title
the association/correlation between changes in patient-reported cognitive symptoms and work productivity. (Perceived Deficit Questionnaire-Depression)
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cognitive function (PDQ-D-20)
Description
Mean change from baseline in cognitive symptoms as measured by PDQ-D-20.
Time Frame
12 and 52 weeks
Title
Cognitive function (Digit Symbol Substitution Test (DSST)
Description
Mean change from baseline in cognitive symptoms as measured by Digit Symbol Substitution Test (DSST).
Time Frame
12 and 52 weeks
Title
Work productivity (WLQ)
Description
mean change from baseline in work productivity as measured by WLQ.
Time Frame
12 and 52 weeks
Title
Work productivity (Work Productivity and Activity Impairment (WPAI) questionnaire)
Description
mean change from baseline in work productivity as measured by Work Productivity and Activity Impairment (WPAI) questionnaire.
Time Frame
12 and 52 weeks
Title
Work productivity (World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12)
Description
mean change from baseline in work productivity as measured by World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12).
Time Frame
12 and 52 weeks
Title
Work productivity (Sheehan Disability Scale (SDS)
Description
mean change from baseline in work productivity as measured by Sheehan Disability Scale (SDS).
Time Frame
12 and 52 weeks
Title
Depressive symptoms (Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR)
Description
mean change from baseline in depressive symptoms as measured by Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR).
Time Frame
12 and 52 weeks
Title
Depressive symptoms (Clinical Global Impression-Improvement (CGI-I) score)
Description
mean change in depressive symptoms as measured by Clinical Global Impression-Improvement (CGI-I) score.
Time Frame
12 and 52 weeks
Title
Depressive symptoms (Clinical Global Impression-Severity (CGI-S)
Description
mean change from baseline in depressive symptoms as measured by Clinical Global Impression-Severity (CGI-S).
Time Frame
12 and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pratap Chokka, M.D.
Organizational Affiliation
Chokka Center for Integrative Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
CA004
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6W6
Country
Canada
Facility Name
CA005
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
CA006
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
CA007
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1M7
Country
Canada
Facility Name
CA016
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 4E2
Country
Canada
Facility Name
CA013
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 1C1
Country
Canada
Facility Name
CA010
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
Facility Name
CA012
City
Fort Erie
State/Province
Ontario
ZIP/Postal Code
L2A 1Z3
Country
Canada
Facility Name
CA017
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
CA026
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
CA011
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 4P2
Country
Canada
Facility Name
CA003
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 4N4
Country
Canada
Facility Name
CA008
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
CA009
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
CA015
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2T 3Y4
Country
Canada
Facility Name
CA022
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3V2
Country
Canada
Facility Name
CA020
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2R 1V6
Country
Canada
Facility Name
CA023
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 0G6
Country
Canada
Facility Name
CA018
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
CA024
City
St-Jean-sur-Richelieu
State/Province
Quebec
ZIP/Postal Code
J2W 1J1
Country
Canada
Facility Name
CA030
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
CA027
City
Westmount
State/Province
Quebec
ZIP/Postal Code
H4A1S9
Country
Canada
Facility Name
CA028
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
CA019
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Facility Name
CA021
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
CA029
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30802419
Citation
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.
Results Reference
derived

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

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