Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (10 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
2 other identifiers
interventional
462
1 country
39
Brief Summary
The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2010
39 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
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 14, 2010
CompletedFirst Posted
Study publicly available on registry
July 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
December 18, 2013
CompletedDecember 18, 2013
October 1, 2013
1.5 years
July 14, 2010
October 25, 2013
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Montgomery-Ă…sberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.
Baseline and Week 8
Secondary Outcomes (5)
Percentage of Participants With a MADRS Response at Week 8
Baseline and Week 8
Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8
Week 8
Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20
Baseline and Week 8
Percentage of Participants in MADRS Remission at Week 8
Week 8
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
Baseline and Week 8
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg
EXPERIMENTALVortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Vortioxetine 20 mg
EXPERIMENTALVortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
Interventions
Encapsulated vortioxetine immediate release tablets
Eligibility Criteria
You may qualify if:
- Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- Has a Montgomery Ă…sberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
- Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.
You may not qualify if:
- Has previously participated in a Lu AA21004 clinical study.
- Has 1 or more the following:
- Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV
- Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.
- Diagnosis of alcohol or other substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least years prior to screening (participant must also have negative urine drug screen prior to Baseline).
- Presence or history of a clinically significant neurological disorder (including epilepsy)
- Neurodegenerative disorder.
- Any Axis II disorder that might compromise the study.
- Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
- Has clinically significant abnormal vital signs as determined by the investigator.
- Has an abnormal Electrocardiogram.
- Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
- Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.
- Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
- Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (39)
Unknown Facility
Anaheim, California, United States
Unknown Facility
Cerritos, California, United States
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
Encino, California, United States
Unknown Facility
Garden Grove, California, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
Pico Rivera, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Norwich, Connecticut, United States
Unknown Facility
Maitland, Florida, United States
Unknown Facility
North Miami, Florida, United States
Unknown Facility
Orange City, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Smyrna, Georgia, United States
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Chicago, Illinois, United States
Unknown Facility
Joliet, Illinois, United States
Unknown Facility
Skokie, Illinois, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Lake Charles, Louisiana, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Saint Charles, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
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Willingboro, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Cinti, Ohio, United States
Unknown Facility
Dayton, Ohio, United States
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Middleburg Heights, Ohio, United States
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Portland, Oregon, United States
Unknown Facility
Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
Unknown Facility
Irving, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Brown Deer, Wisconsin, United States
Related Publications (3)
Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26.
PMID: 36708956DERIVEDChristensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.
PMID: 31818787DERIVEDJacobsen PL, Mahableshwarkar AR, Serenko M, Chan S, Trivedi MH. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with major depressive disorder. J Clin Psychiatry. 2015 May;76(5):575-82. doi: 10.4088/JCP.14m09335.
PMID: 26035185DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Clinical Science
- 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 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2010
First Posted
July 15, 2010
Study Start
July 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
December 18, 2013
Results First Posted
December 18, 2013
Record last verified: 2013-10