Overview

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

Status:
Completed
Trial end date:
2017-07-06
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lundbeck Canada Inc.
Treatments:
Vortioxetine
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.