An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
NCT ID: NCT00734071
Last Updated: 2013-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2008-06-30
2009-03-31
Brief Summary
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Detailed Description
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The study enrolled 304 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
* Vortioxetine 5 mg
* Placebo (dummy inactive pill) - 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 7 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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Placebo
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Placebo
Vortioxetine placebo-matching capsules
Vortioxetine 5 mg
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 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 Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline.
* Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
* Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline.
Exclusion Criteria
* Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview \[MINI\]).
* 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® and subject must have a negative urine drug screen prior to Baseline.
* 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.
* Is taking excluded medications.
* Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
* Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
* 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.
* Has a clinically significant unstable illness.
* Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level greater than 1.5 times the upper limit of normal.
* Has a serum creatinine of greater than 1.5 times the upper limit of normal.
* Has a previous history of cancer that had been in remission for less than 5 years.
* Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator.
* Has an abnormal electrocardiogram.
18 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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Anaheim, California, United States
Arcadia, California, United States
Irvine, California, United States
National City, California, United States
Sherman Oaks, California, United States
Upland, California, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Coral Gables, Florida, United States
North Miami, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Oak Brook, Illinois, United States
Park Ridge, Illinois, United States
Lafayette, Indiana, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Fall River, Massachusetts, United States
Worcester, Massachusetts, United States
Flowood, Mississippi, United States
Brooklyn, New York, United States
New York, New York, United States
The Bronx, New York, United States
Morganton, North Carolina, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Lincoln, Rhode Island, United States
Memphis, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Charleston, West Virginia, United States
Countries
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References
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Rothschild AJ, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV. Vortioxetine (Lu AA21004) 5 mg in generalized anxiety disorder: results of an 8-week randomized, double-blind, placebo-controlled clinical trial in the United States. Eur Neuropsychopharmacol. 2012 Dec;22(12):858-66. doi: 10.1016/j.euroneuro.2012.07.011. Epub 2012 Aug 15.
Other Identifiers
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U1111-1114-4876
Identifier Type: REGISTRY
Identifier Source: secondary_id
LuAA21004_310
Identifier Type: -
Identifier Source: org_study_id