Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
NCT ID: NCT00672620
Last Updated: 2013-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
611 participants
INTERVENTIONAL
2008-04-30
2008-12-31
Brief Summary
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Detailed Description
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The study enrolled 611 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
* Vortioxetine 2.5 mg
* Vortioxetine 5 mg
* Duloxetine 10 mg
* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.
All participants were asked to take one capsule at the same time each day throughout the study.
This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 12 weeks. Participants made 8 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vortioxetine 2.5 mg
Vortioxetine 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
Encapsulated vortioxetine immediate-release tablets
Vortioxetine 5 mg
Vortioxetine 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
Encapsulated vortioxetine immediate-release tablets
Duloxetine 60 mg
Duloxetine 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.
Duloxetine
Duloxetine capsules
Placebo
Placebo-matching capsules, orally, once daily for up to 9 weeks.
Placebo
Placebo-matching capsules
Interventions
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Vortioxetine
Encapsulated vortioxetine immediate-release tablets
Duloxetine
Duloxetine capsules
Placebo
Placebo-matching capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The reported duration of the current major depressive episode is at least 3 months.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Beverly Hills, California, United States
Irvine, California, United States
Santa Ana, California, United States
Torrance, California, United States
Upland, California, United States
Bradenton, Florida, United States
Coral Springs, Florida, United States
Fort Walton Beach, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Smyrna, Georgia, United States
Chicago, Illinois, United States
Libertyville, Illinois, United States
Oak Brook, Illinois, United States
Prairie Village, Kansas, United States
Owensboro, Kentucky, United States
Baltimore, Maryland, United States
Pittsfield, Massachusetts, United States
Worcester, Massachusetts, United States
Flowood, Mississippi, United States
New York, New York, United States
Olean, New York, United States
Beachwood, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Allenport, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Memphis, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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U1111-1114-3497
Identifier Type: REGISTRY
Identifier Source: secondary_id
LuAA21004_304
Identifier Type: -
Identifier Source: org_study_id