Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder
NCT ID: NCT02972632
Last Updated: 2019-07-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
123 participants
INTERVENTIONAL
2016-12-22
2018-02-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vortioxetine for Menopausal Depression
NCT02234362
Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine
NCT02332954
THINC-it Vortioxetine - Sensitivity to Change
NCT03053362
Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers
NCT02637466
Making Decisions About Depression Medications
NCT01502891
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study enrolled 123 patients. Participants will receive:
• Vortioxetine 10 to 20 mg
All participants will be asked to take one tablet at the same time each day throughout the study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to 20 mg. The dose may then be decreased by 5 mg based on participant's response and tolerability to higher dose as judged by the Investigator.
This multi-center trial will be conducted in Unites States. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vortioxetine 10-20 mg
Vortioxetine 10 mg, tablets, orally, once daily followed by a dose adjustment to a maximum of 20 mg, tablets, orally, once daily up to 12 weeks. The dose may be decreased by 5 mg based on participant's response and tolerability as judged by the investigator.
Vortioxetine
Vortioxetine tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vortioxetine
Vortioxetine tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. The antidepressant treatment must be on-going at time of Screening or have been discontinued within the 6 weeks prior to Screening.
4. Is considered appropriate for a change in antidepressant medication based on Investigator judgment in collaboration with the participant.
5. Has scores on Patient Health Questionnaire (PHQ-9) ≥5 and Clinical Global Impression Scale Severity (CGI-S ≥4).
Exclusion Criteria
2. 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.
3. 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).
4. 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.
5. Has 1 or more of the following:
1. 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.
2. 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.
3. Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
4. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
6. Has a known history of acute narrow-angle glaucoma or is at risk of acute narrow-angle glaucoma.
7. 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.
8. Has active hepatitis B or a known history of hepatitis C virus.
9. Has a known history of human immunodeficiency virus infection.
10. Has a history of gastric bypass.
11. Has previously or is currently participating in this study or another vortioxetine or LuAA21004 study.
12. 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
McCue M, Sarkey S, Eramo A, Francois C, Parikh SV. Using the Goal Attainment Scale adapted for depression to better understand treatment outcomes in patients with major depressive disorder switching to vortioxetine: a phase 4, single-arm, open-label, multicenter study. BMC Psychiatry. 2021 Dec 11;21(1):622. doi: 10.1186/s12888-021-03608-1.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1185-6902
Identifier Type: OTHER
Identifier Source: secondary_id
Vortioxetine-4003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.