Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
2 other identifiers
interventional
611
1 country
38
Brief Summary
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), 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 P75+ for phase_3 major-depressive-disorder
Started Apr 2008
Shorter than P25 for phase_3 major-depressive-disorder
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
December 18, 2013
CompletedDecember 18, 2013
October 1, 2013
7 months
May 2, 2008
October 25, 2013
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate.
Baseline and Week 8
Secondary Outcomes (11)
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
Baseline and Weeks 1, 2, 4, and 6
Percentage of Responders in HAM-D 24 Total Score by Study Visit
Baseline and Weeks 1, 2, 4, 6 and 8.
Percentage of Participants With a Sustained Response in HAM-D24
Baseline to Week 8
Percentage of Participants in MADRS Remission at Week 8
Week 8
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
Baseline and Weeks 1, 2, 4, 6 and 8
- +6 more secondary outcomes
Study Arms (4)
Vortioxetine 2.5 mg
EXPERIMENTALVortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
Vortioxetine 5 mg
EXPERIMENTALVortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
Duloxetine 60 mg
ACTIVE COMPARATORDuloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsules, orally, once daily for 1 week after the treatment period.
Placebo
PLACEBO COMPARATORPlacebo-matching capsules, orally, once daily for up to 9 weeks.
Interventions
Encapsulated vortioxetine immediate-release tablets
Eligibility Criteria
You may qualify if:
- Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
- The reported duration of the current major depressive episode is at least 3 months.
You may not qualify if:
- Has 1 or more the following:
- Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
- Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- Any Axis II disorder that might compromise the study.
- Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
- The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- Has received electroconvulsive therapy within 6 months prior to Screening.
- Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- H. Lundbeck A/Scollaborator
Study Sites (38)
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Upland, California, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Coral Springs, Florida, United States
Unknown Facility
Fort Walton Beach, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Maitland, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
South Miami, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Smyrna, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Libertyville, Illinois, United States
Unknown Facility
Oak Brook, Illinois, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Owensboro, Kentucky, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Pittsfield, Massachusetts, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Flowood, Mississippi, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Olean, New York, United States
Unknown Facility
Beachwood, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Allenport, Pennsylvania, United States
Unknown Facility
Lancaster, Pennsylvania, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Related Publications (1)
Mahableshwarkar AR, Jacobsen PL, Chen Y. A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder. Curr Med Res Opin. 2013 Mar;29(3):217-26. doi: 10.1185/03007995.2012.761600. Epub 2013 Jan 17.
PMID: 23252878RESULT
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 6, 2008
Study Start
April 1, 2008
Primary Completion
November 1, 2008
Study Completion
December 1, 2008
Last Updated
December 18, 2013
Results First Posted
December 18, 2013
Record last verified: 2013-10