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.