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

NCT ID: NCT02332954

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-07-06

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vortioxetine naive

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

Group Type: OTHER

vortioxetine

Intervention Type: DRUG

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.

Switch

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

Group Type: OTHER

vortioxetine

Intervention Type: DRUG

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.

Interventions

vortioxetine

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.

Intervention Type: DRUG

Other Intervention Names

Trintellix

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lundbeck Canada Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pratap Chokka, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chokka Center for Integrative Health

Locations

CA004

Edmonton, Alberta, Canada

CA005

Kelowna, British Columbia, Canada

CA006

St. John's, Newfoundland and Labrador, Canada

CA007

Halifax, Nova Scotia, Canada

CA016

Burlington, Ontario, Canada

CA013

Chatham, Ontario, Canada

CA010

Corunna, Ontario, Canada

CA012

Fort Erie, Ontario, Canada

CA017

Hamilton, Ontario, Canada

CA026

Hamilton, Ontario, Canada

CA011

London, Ontario, Canada

CA003

Mississauga, Ontario, Canada

CA008

Sarnia, Ontario, Canada

CA009

Sarnia, Ontario, Canada

CA015

St. Catharines, Ontario, Canada

CA022

Montreal, Quebec, Canada

CA020

Montreal, Quebec, Canada

CA023

Montreal, Quebec, Canada

CA018

Pointe-Claire, Quebec, Canada

CA024

Saint-Jean-sur-Richelieu, Quebec, Canada

CA030

Victoriaville, Quebec, Canada

CA027

Westmount, Quebec, Canada

CA028

Saskatoon, Saskatchewan, Canada

CA019

Québec, , Canada

CA021

Québec, , Canada

CA029

Québec, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30802419 (View on PubMed)

Other Identifiers

15913A

Identifier Type: -

Identifier Source: org_study_id