Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
NCT ID: NCT00730691
Last Updated: 2013-12-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
781 participants
INTERVENTIONAL
2008-06-30
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. Participants who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo-matching capsules, orally, once daily for up to 9 weeks.
Placebo
Placebo-matching capsules
Vortioxetine 2.5 mg
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
Placebo
Placebo-matching capsules
Vortioxetine
Encapsulated vortioxetine immediate release tablets
Vortioxetine 5 mg
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
Placebo
Placebo-matching capsules
Vortioxetine
Encapsulated vortioxetine immediate release tablets
Vortioxetine 10 mg
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
Placebo
Placebo-matching capsules
Vortioxetine
Encapsulated vortioxetine immediate release tablets
Duloxetine 60 mg
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
Duloxetine
Overencapsulated duloxetine capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Placebo-matching capsules
Vortioxetine
Encapsulated vortioxetine immediate release tablets
Duloxetine
Overencapsulated duloxetine capsules
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* Received Lu AA21004 in a previous clinical study.
* Was a study site employee, or an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study.
* Has 1 or more of the following:
* 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 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.
* Has known sensitivity to duloxetine.
* 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 inhibitor 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 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.
* Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level \>1.5 times the upper limit of normal.
* Has a serum creatinine level \>1.5 upper limit of normal.
* Has a previous history of cancer that had been in remission for less than 5 years.
* Hasclinically significant abnormal vital signs as determined by the investigator.
* Has a history of lack of response to previous adequate treatment with duloxetine for any Generalized Anxiety Disorder episode.
* Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit
* Has a thyroid stimulating hormone value outside the normal range.
* Has an abnormal electrocardiogram.
* has a disease or was taking medications that, in the opinion of the investigator, could have interfered with the assessments of safety, tolerability, or efficacy.
* The patient, in the opinion of the investigator, was unlikely to comply with the clinical study protocol or was unsuitable for any reason.
* Had previously been enrolled in this study.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
H. Lundbeck A/S
INDUSTRY
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anaheim, California, United States
Beverly Hills, California, United States
Fresno, California, United States
Los Angeles, California, United States
Oceanside, California, United States
San Diego, California, United States
Sherman Oaks, California, United States
Widomar, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Norwalk, Connecticut, United States
Coral Gables, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Roswell, Georgia, United States
Smyrna, Georgia, United States
Honolulu, Hawaii, United States
Oakbrook Ter, Illinois, United States
Terre Haute, Indiana, United States
Owensboro, Kentucky, United States
Shreveport, Louisiana, United States
Rockville, Maryland, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Nashua, New Hampshire, United States
Clementon, New Jersey, United States
Princeton, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Cedarhurst, New York, United States
New York, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Beachwood, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Salem, Oregon, United States
Allentown, Pennsylvania, United States
Media, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
DeSoto, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
Wichita Falls, Texas, United States
Midvale, Utah, United States
Woodstock, Vermont, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Brown Deer, Wisconsin, United States
Middleton, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mahableshwarkar AR, Jacobsen PL, Chen Y, Simon JS. A randomised, double-blind, placebo-controlled, duloxetine-referenced study of the efficacy and tolerability of vortioxetine in the acute treatment of adults with generalised anxiety disorder. Int J Clin Pract. 2014 Jan;68(1):49-59. doi: 10.1111/ijcp.12328.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1114-3966
Identifier Type: REGISTRY
Identifier Source: secondary_id
LuAA21004_308
Identifier Type: -
Identifier Source: org_study_id