Real-life Effectiveness of Vortioxetine in Depression

Completed

Conditions studied: Major Depressive Disorder

In brief

Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences. Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice. The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life. This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.

Key facts

Study ID

NCT03555136

Run by

H. Lundbeck A/S

People needed

992

Starts

2017-11-17

Expected to finish

2021-01-31

Last updated by the study team

2021-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is ≥18 years
• The patient is an outpatient, treated in a GP or psychiatric outpatient practice
• The patient has a diagnosis of major depressive episode according to local diagnostic criteria
• The patient has been prescribed vortioxetine according to the local Summary of Product Characteristics (SmPC)

You may not qualify if…

• The patient is unable to read and understand the information sheet and informed consent form or the Patient Reported Outcomes (PRO)
• The patient is concurrently participating in a clinical trial
• The patient has a diagnosis of schizophrenia or other psychotic disorder according to local diagnostic criteria
• The patient has a diagnosis of bipolar disorder according to local diagnostic criteria
• The patient has a substance use disorders other than tobacco use disorder
• The patient has dementia or other neurodegenerative disease significantly impacting cognitive functioning
• The patient has a mood disorder due to a general medical condition or substances
• The patient is pregnant, ≤6 months post-partum or breastfeeding
• The patient is at significant risk of suicide in the investigator's opinion or the patient has attempted suicide within the last six months
• The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel

Where it is running

• Center For Advanced Improvement (US0011) — Tucson, Arizona, United States
• Pharmacology Research Institute (US0045) — Newport Beach, California, United States
• North County Clinical Research (Nccr) (US0071) — Oceanside, California, United States
• Breakthrough Clinical Trials (US0074) — San Bernardino, California, United States
• Viking Clinical Research Center LLC (US0033) — Temecula, California, United States
• Da Vinci Research Institute (US0063) — Boca Raton, Florida, United States
• Sarkis Clinical Trials (US0066) — Gainesville, Florida, United States
• Maxblue Institute (US0038) — Hialeah, Florida, United States
• Office Of Amit Vijapura, Md (US0057) — Jacksonville, Florida, United States
• International Research Associates LLC (US0060) — Miami, Florida, United States
• Millenia Psychiatry and Research, Inc. (US0015) — Orlando, Florida, United States
• Professional Health Care of Pinellas (US0050) — St. Petersburg, Florida, United States
• Northwest Behavioral Research Center (US0007) — Marietta, Georgia, United States
• Pearl Health Clinic (US0001) — Ammon, Idaho, United States
• Southern Illinois Associates LLC (US0079) — Glen Carbon, Illinois, United States
• AMR- Baber Research, Inc. (US0006) — Naperville, Illinois, United States
• University Of Kansas Cancer Center (US0078) — Kansas City, Kansas, United States
• Neuroscientific Insights (US0029) — Rockville, Maryland, United States
• Rochester Center For Behavioral Medicine (US0059) — Rochester Hills, Michigan, United States
• St. Charles Psychiatric Associates - Midwest Research Group (US0039) — Saint Charles, Missouri, United States
• Alivation Research, LLC (US0020) — Lincoln, Nebraska, United States
• Meridian Clinical Research (US0027) — Norfolk, Nebraska, United States
• Finger Lakes Clinical Research (US0005) — Rochester, New York, United States
• Quest Therapeutics Of Avon Lake (US0002) — Avon Lake, Ohio, United States
• Harmonex Neuroscience Research Inc (US0072) — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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