An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of Single Dose of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
2 other identifiers
interventional
304
1 country
33
Brief Summary
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2008
Shorter than P25 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
December 18, 2013
CompletedDecember 18, 2013
October 1, 2013
7 months
August 11, 2008
October 25, 2013
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Baseline to Week 8
Secondary Outcomes (24)
Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8
Baseline to Week 8
Clinical Global Impression Scale-Global Improvement at Week 8
Baseline to Week 8
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
Baseline to Week 8
Percentage of Responders in HAM-A Total Score at Week 8
Baseline and Week 8
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
Baseline to Week 8
- +19 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORVortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg
EXPERIMENTALVortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Interventions
Encapsulated vortioxetine immediate-release tablets
Eligibility Criteria
You may qualify if:
- Has a primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) 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.
You may not qualify if:
- 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 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- H. Lundbeck A/Scollaborator
Study Sites (33)
Unknown Facility
Anaheim, California, United States
Unknown Facility
Arcadia, California, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
National City, California, United States
Unknown Facility
Sherman Oaks, California, United States
Unknown Facility
Upland, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
North Miami, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Oak Brook, Illinois, United States
Unknown Facility
Park Ridge, Illinois, United States
Unknown Facility
Lafayette, Indiana, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Fall River, Massachusetts, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Flowood, Mississippi, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Morganton, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Lincoln, Rhode Island, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Charleston, West Virginia, United States
Related Publications (1)
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.
PMID: 22901736RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Clinical Science
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director, Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 13, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2009
Study Completion
March 1, 2009
Last Updated
December 18, 2013
Results First Posted
December 18, 2013
Record last verified: 2013-10