Clinical trial NCT02332954: Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
Cognition
Cognitive symptoms
vortioxetine
real life
naturalistic
Lead sponsor: Lundbeck Canada Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the association/correlation between changes in patient-reported cognitive symptoms and work productivity. (Perceived Deficit Questionnaire-Depression)
timeFrame: 12 weeks
Secondary outcomes:
measure: Cognitive function (PDQ-D-20)
timeFrame: 12 and 52 weeks
measure: Cognitive function (Digit Symbol Substitution Test (DSST)
timeFrame: 12 and 52 weeks
measure: Work productivity (WLQ)
timeFrame: 12 and 52 weeks
measure: Work productivity (Work Productivity and Activity Impairment (WPAI) questionnaire)
timeFrame: 12 and 52 weeks
measure: Work productivity (World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12)
timeFrame: 12 and 52 weeks
measure: Work productivity (Sheehan Disability Scale (SDS)
timeFrame: 12 and 52 weeks
measure: Depressive symptoms (Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR)
timeFrame: 12 and 52 weeks
measure: Depressive symptoms (Clinical Global Impression-Improvement (CGI-I) score)
timeFrame: 12 and 52 weeks
measure: Depressive symptoms (Clinical Global Impression-Severity (CGI-S)
timeFrame: 12 and 52 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: CA004
state: Alberta
city: Kelowna
country: Canada
facility: CA005
state: British Columbia
city: St. John's
country: Canada
facility: CA006
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: CA007
state: Nova Scotia
city: Burlington
country: Canada
facility: CA016
state: Ontario
city: Chatham
country: Canada
facility: CA013
state: Ontario
city: Corunna
country: Canada
facility: CA010
state: Ontario
city: Fort Erie
country: Canada
facility: CA012
state: Ontario
city: Hamilton
country: Canada
facility: CA017
state: Ontario
city: Hamilton
country: Canada
facility: CA026
state: Ontario
city: London
country: Canada
facility: CA011
state: Ontario
city: Mississauga
country: Canada
facility: CA003
state: Ontario
city: Sarnia
country: Canada
facility: CA008
state: Ontario
city: Sarnia
country: Canada
facility: CA009
state: Ontario
city: St. Catharines
country: Canada
facility: CA015
state: Ontario
city: Montreal
country: Canada
facility: CA022
state: Quebec
city: Montreal
country: Canada
facility: CA020
state: Quebec
city: Montreal
country: Canada
facility: CA023
state: Quebec
city: Pointe-Claire
country: Canada
facility: CA018
state: Quebec
city: St-Jean-sur-Richelieu
country: Canada
facility: CA024
state: Quebec
city: Victoriaville
country: Canada
facility: CA030
state: Quebec
city: Westmount
country: Canada
facility: CA027
state: Quebec
city: Saskatoon
country: Canada
facility: CA028
state: Saskatchewan
city: Quebec
country: Canada
facility: CA019
city: Quebec
country: Canada
facility: CA021
city: Quebec
country: Canada
facility: CA029
Study officials:
affiliation: Chokka Center for Integrative Health
name: Pratap Chokka, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.