Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
NCT ID: NCT00707980
Last Updated: 2013-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
836 participants
INTERVENTIONAL
2008-06-30
2010-08-31
Brief Summary
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Detailed Description
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The study enrolled 836 patients that had completed one of two other vortioxetine studies. Participants received 5 mg of vortioxetine for the first week of treatment. After completing the first week of treatment, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day based on participant's response as judged by the doctor.
All participants were asked to take one encapsulated tablet at the same time each day throughout the study.
This multi-center trial was conducted worldwide. The overall time to participate in this study was up to 56 weeks. Participants made 13 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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vortioxetine
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
Vortioxetine
Encapsulated vortioxetine immediate-release tablets
Interventions
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Vortioxetine
Encapsulated vortioxetine immediate-release tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 (classification code 296.xx) at entry into the prior Lu AA21004\_304 or Lu AA21004\_305 study.
Exclusion Criteria
* The participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale.
* The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
* Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
* Has used/uses disallowed concomitant medication.
18 Years
76 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
Elizabeth Vale, , Australia
Richmond, , Australia
Southport, , Australia
Osijek, , Croatia
Zagreb, , Croatia
Bully-les-Mines, , France
Marseille, , France
Strasbourg, , France
Berlin, , Germany
Bochum, , Germany
Chemnitz, , Germany
Hüttenberg, , Germany
Leipzig, , Germany
München, , Germany
Nuremberg, , Germany
Wiesbaden, , Germany
Liepāja, , Latvia
Riga, , Latvia
Sigulda, , Latvia
Šiauliai, , Lithuania
Vilnius, , Lithuania
Kuala Lumpur, , Malaysia
SchHoogfliet, , Netherlands
Wildervank, , Netherlands
Zwijndrecht, , Netherlands
Bialystok, , Poland
Leszno, , Poland
Pruszków, , Poland
Skórzewo, , Poland
Torun, , Poland
Tuszyn, , Poland
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Stavropol, , Russia
Tomsk, , Russia
Belgrade, , Serbia
Bryanston, , South Africa
Durban, , South Africa
Lyttelton, , South Africa
Noordheuwel, , South Africa
Pretoria, , South Africa
Buchon, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Kaohsiung City, , Taiwan
Dnipro, , Ukraine
Kiev, , Ukraine
Luhansk, , Ukraine
Simferopol, , Ukraine
Glasgow, , United Kingdom
Countries
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Other Identifiers
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2008-001581-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1113-9564
Identifier Type: REGISTRY
Identifier Source: secondary_id
LuAA21004_301
Identifier Type: -
Identifier Source: org_study_id