Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
NCT ID: NCT01163266
Last Updated: 2013-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
462 participants
INTERVENTIONAL
2010-07-31
2012-01-31
Brief Summary
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Detailed Description
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The study enrolled 462 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
* Vortioxetine 10 mg
* Vortioxetine 20 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 13 weeks. Participants made 9 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
QUADRUPLE
Study Groups
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Placebo
Placebo-matching capsules, orally, once daily for up to 8 weeks.
Placebo
Vortioxetine placebo-matching capsules
Vortioxetine 10 mg
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Vortioxetine
Encapsulated vortioxetine immediate release tablets
Vortioxetine 20 mg
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
Vortioxetine
Encapsulated vortioxetine immediate release tablets
Interventions
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Vortioxetine
Encapsulated vortioxetine immediate release tablets
Placebo
Vortioxetine placebo-matching capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a Montgomery Åsberg 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.
Exclusion Criteria
* 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.
* Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. For the purposes of this protocol the following conditions are considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
* Has a significant risk of suicide according to the investigator's opinion.
18 Years
75 Years
ALL
No
Sponsors
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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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Anaheim, California, United States
Cerritos, California, United States
Costa Mesa, California, United States
Encino, California, United States
Garden Grove, California, United States
Irvine, California, United States
Pico Rivera, California, United States
Riverside, California, United States
Colorado Springs, Colorado, United States
Norwich, Connecticut, United States
Maitland, Florida, United States
North Miami, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Smyrna, Georgia, United States
Chicago, Illinois, United States
Joliet, Illinois, United States
Skokie, Illinois, United States
Wichita, Kansas, United States
Lake Charles, Louisiana, United States
Worcester, Massachusetts, United States
Saint Charles, Missouri, United States
St Louis, Missouri, United States
Willingboro, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
Cinti, Ohio, United States
Dayton, Ohio, United States
Middleburg Heights, Ohio, United States
Portland, Oregon, United States
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Irving, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Brown Deer, Wisconsin, United States
Countries
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References
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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.
Christensen 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.
Jacobsen 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.
Other Identifiers
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U1111-1115-8770
Identifier Type: REGISTRY
Identifier Source: secondary_id
LuAA21004_316
Identifier Type: -
Identifier Source: org_study_id