Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder

Completed · Phase 4

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD).

Key facts

Study ID: NCT02972632
Run by: Takeda
People needed: 123
Starts: 2016-12-22
Expected to finish: 2018-02-06
Last updated by the study team: 2019-07-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Is suffering from Major Depressive Disorder (MDD) as the primary psychiatric diagnosis.
Has been or is currently being treated with an approved antidepressant (monotherapy) for 6 weeks or longer at an adequate therapeutic dose. Participants currently on an antidepressant at Screening will be discontinued in a manner that is consistent with labeling recommendations and conventional medical practice.
The antidepressant treatment must be on-going at time of Screening or have been discontinued within the 6 weeks prior to Screening.
Is considered appropriate for a change in antidepressant medication based on Investigator judgment in collaboration with the participant.
Has scores on Patient Health Questionnaire (PHQ-9) ≥5 and Clinical Global Impression Scale Severity (CGI-S ≥4).

You may not qualify if…

Has discontinued prior antidepressant treatment greater than 6 weeks from Screening.
Is considered to be at imminent risk for hospitalization due to severe depression in the opinion of the investigator. Recent hospitalization due to MDD within 3 months prior to Screening is exclusionary also.
Has a significant risk of suicide according to the Investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening or scores "yes" on items 4 or 5 in the past 6 months on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS).
Is considered to be treatment resistant, defined as participants with MDD who have not responded to 2 or more separate different antidepressant monotherapy trials of adequate dose and duration (6 weeks or longer) in their current episode. History of only responding to combination or augmentation therapy in previous major depressive episode (MDEs) is also considered evidence of treatment resistant depression.
Has 1 or more of the following:
Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as determined by the investigator.
Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine). The participants must have a negative urine drug screen (UDS) at Screening and Baseline, this includes benzodiazepines and opiates (including oxycodone) for which there is no prescription.
Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Has a known history of acute narrow-angle glaucoma or is at risk of acute narrow-angle glaucoma.
Has a known unstable thyroid disorder or a thyroid-stimulating hormone value outside the normal range based on medical history that is deemed clinically significant by the investigator.
Has active hepatitis B or a known history of hepatitis C virus.
Has a known history of human immunodeficiency virus infection.
Has a history of gastric bypass.
Has previously or is currently participating in this study or another vortioxetine or LuAA21004 study.
Is receiving or who have started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plan to initiate such therapy during the study.

Where it is running

ATP Clinical Research, Inc. — Costa Mesa, California, United States
ProScience Research Group — Culver City, California, United States
Behavioral Research Specialists, LLC — Glendale, California, United States
Pacific Research Partners — Oakland, California, United States
Excell Research — Oceanside, California, United States
Anderson Clinical Research — Redlands, California, United States
University Medical Group — Upland, California, United States
MCB Clinical Research Centers, LLC — Colorado Springs, Colorado, United States
Suncoast Clinical Research Inc. — New Port Richey, Florida, United States
Behavioral Clinical Research , Inc — North Miami, Florida, United States
Compass Research Main — Orlando, Florida, United States
University of South Florida — Tampa, Florida, United States
Great Lakes Clinical Trials — Chicago, Illinois, United States
Baber Research Group — Naperville, Illinois, United States
Deaconess Clinic — Evansville, Indiana, United States
Novex Clinical Research, LLC — New Bedford, Massachusetts, United States
Coastal Research Associates, Inc. — South Weymouth, Massachusetts, United States
University of Michigan, Ann Arbor — Ann Arbor, Michigan, United States
Columbia University Medical Center — New York, New York, United States
Dayton Clinical Research — Dayton, Ohio, United States
Green & Seidner Family Practice Associates — Lansdale, Pennsylvania, United States
Relaro Medical Trials — Dallas, Texas, United States
Red Oak Psychiatry Associates, PA — Houston, Texas, United States
Radiant Research, Inc. — San Antonio, Texas, United States
Family Psychiatry of The Woodlands — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.