Real-life Effectiveness of Vortioxetine in Depression

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Vortioxetine

• Registration Number: NCT03555136
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-17
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-13
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 992

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients initiating vortioxetine treatment	Vortioxetine	Patients with major depressive disorder initiating treatment with vortioxetine

Primary Outcome Measures

Name	Time	Method
Sheehan Disability Scale (SDS)	Change since baseline at week 12 and 24	A series of patient self-rated, scales designed to measure the extent to which his or her 1) work or school, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms

Secondary Outcome Measures

Name	Time	Method
Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5)	Change since baseline at week 12 and 24	A self-reported rating scale that aims to assess perceived cognitive deficits from the patient's perspective
The Patient Health Questionnaire - nine items (PHQ-9)	Change since baseline at week 12 and 24	A patient-rated scale designed to assess depression based on the nine DSM-IV criteria for depression

Trial Locations

Locations (106)

Harmonex Neuroscience Research Inc (US0072); 🇺🇸 Dothan, Alabama, United States

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

Scroll for more (96 remaining)