Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder
An Open-Label, Single-Arm, Multicenter, Prospective, Phase 4, Interventional, Flexible Dose Study to Evaluate the Effectiveness of Vortioxetine on Goal Achievement After a Change in Antidepressant Medication for the Treatment of Subjects With Major Depressive Disorder
2 other identifiers
interventional
123
1 country
25
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 major-depressive-disorder
Started Dec 2016
Shorter than P25 for phase_4 major-depressive-disorder
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2016
CompletedFirst Posted
Study publicly available on registry
November 23, 2016
CompletedStudy Start
First participant enrolled
December 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2018
CompletedResults Posted
Study results publicly available
July 11, 2019
CompletedJuly 11, 2019
June 1, 2019
1.1 years
November 21, 2016
February 6, 2019
June 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12
GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at the outset of study. Another evaluation took place at end of study (EOS) visit to determine the level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with a standard deviation (SD) of 10. Higher score indicates composite of 3 goals (50 or above) as response.
Week 12
Secondary Outcomes (7)
Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12
Baseline and Weeks 6 and 12
Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12
Baseline and Weeks 6 and 12
Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12
Baseline and Weeks 6 and 12
Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12
Baseline and Week 12
Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12
Baseline and Week 12
- +2 more secondary outcomes
Study Arms (1)
Vortioxetine 10-20 mg
EXPERIMENTALVortioxetine 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.
Interventions
Eligibility Criteria
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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (25)
ATP Clinical Research, Inc.
Costa Mesa, California, 92626, United States
ProScience Research Group
Culver City, California, 90230, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Pacific Research Partners
Oakland, California, 94607, United States
Excell Research
Oceanside, California, 92056, United States
Anderson Clinical Research
Redlands, California, 92374, United States
University Medical Group
Upland, California, 91207, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910, United States
Suncoast Clinical Research Inc.
New Port Richey, Florida, 34652, United States
Behavioral Clinical Research , Inc
North Miami, Florida, 33162, United States
Compass Research Main
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33613, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Baber Research Group
Naperville, Illinois, 60563, United States
Deaconess Clinic
Evansville, Indiana, 47713-1227, United States
Novex Clinical Research, LLC
New Bedford, Massachusetts, 2740, United States
Coastal Research Associates, Inc.
South Weymouth, Massachusetts, 2190, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, 48109, United States
Columbia University Medical Center
New York, New York, 10023, United States
Dayton Clinical Research
Dayton, Ohio, 45406, United States
Green & Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446, United States
Relaro Medical Trials
Dallas, Texas, 75243, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381, United States
Related Publications (1)
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.
PMID: 34895181DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2016
First Posted
November 23, 2016
Study Start
December 22, 2016
Primary Completion
February 6, 2018
Study Completion
February 6, 2018
Last Updated
July 11, 2019
Results First Posted
July 11, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.