Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
NCT ID: NCT00731120
Last Updated: 2013-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
457 participants
INTERVENTIONAL
2008-06-30
2009-02-28
Brief Summary
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Detailed Description
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Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitment time is up to 12 weeks.
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 2.5 mg
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks.
Vortioxetine
Encapsulated vortioxetine immediate-release tablets
Vortioxetine 10 mg
Vortioxetine 10 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 ≥ 20.
* Has a Hamilton Anxiety Scale score ≥ 2 on both item 1 (anxious mood) and item 2 (tension).
* Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.
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 participant 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 ≥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 \> 1.5 times the upper limit of normal.
* Has a serum creatinine of \> 1.5 × 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.
* 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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Birmingham, Alabama, United States
Anaheim, California, United States
Cerritos, California, United States
Costa Mesa, California, United States
Orange, California, United States
Redlands, California, United States
Cromwell, Connecticut, United States
Norwich, Connecticut, United States
Hockessin, Delaware, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Lady Lake, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Libertyville, Illinois, United States
Valparaiso, Indiana, United States
Overland Park, Kansas, United States
Prairie Village, Kansas, United States
Boston, Massachusetts, United States
Braintree, Massachusetts, United States
Pittsfield, Massachusetts, United States
St Louis, Missouri, United States
Cherry Hill, New Jersey, United States
Fresh Meadows, New York, United States
New York, New York, United States
Olean, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Emmaus, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Reading, Pennsylvania, United States
North Charleston, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Midlothian, Virginia, United States
Waukesha, Wisconsin, United States
Countries
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References
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Mahableshwarkar AR, Jacobsen PL, Serenko M, Chen Y. A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 and 10 mg in acute treatment of adults with generalized anxiety disorder. Hum Psychopharmacol. 2014 Jan;29(1):64-72. doi: 10.1002/hup.2371.
Other Identifiers
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U1111-1114-2380
Identifier Type: REGISTRY
Identifier Source: secondary_id
LuAA21004_309
Identifier Type: -
Identifier Source: org_study_id