Clinical trial NCT00734071: An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Mood Disorder
Affective Disorder
Anxiety Disorder
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2008-08-13
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.

Detailed description: The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8
timeFrame: Baseline to Week 8
measure: Clinical Global Impression Scale-Global Improvement at Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
timeFrame: Baseline to Week 8
measure: Percentage of Responders in HAM-A Total Score at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
timeFrame: Baseline to Week 8
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
timeFrame: Baseline to Weeks 1, 2, 4 and 6.
measure: Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed
timeFrame: Baseline to Weeks 1 and 4
measure: Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed
timeFrame: Baseline to Weeks 1, 2, 4 and 6
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed
timeFrame: Baseline to Weeks 1, 2 and 4
measure: Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
timeFrame: Baseline and Weeks 1, 2, 4 and 6
measure: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
timeFrame: Baseline to Weeks 1, 2, 4 and 6
measure: Percentage of Participants in HAM-A Remission at Each Week Assessed
timeFrame: Weeks 1, 2, 4, 6 and 8
measure: Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed
timeFrame: Baseline to Weeks 1, 2, 4, 6 and 8
measure: Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed
timeFrame: Baseline to Weeks 1, 4 and 8
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed
timeFrame: Baseline to Weeks 2 and 4
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed
timeFrame: Baseline to Weeks 2, 4 and 8
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed
timeFrame: Baseline to Weeks 2, 4 and 8
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed
timeFrame: Baseline to Weeks 2, 4 and 8
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed
timeFrame: Baseline to Weeks 2, 4 and 8
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed
timeFrame: Baseline to Weeks 2, 4 and 8
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed
timeFrame: Baseline to Weeks 2, 4 and 8
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed
timeFrame: Baseline to Weeks 2, 4 and 8
measure: Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Arcadia
country: United States
state: California
city: Irvine
country: United States
state: California
city: National City
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Upland
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Oak Brook
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Lafayette
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Fall River
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Flowood
country: United States
state: Mississippi
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Morganton
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Lincoln
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charleston
country: United States
state: West Virginia
Study officials:
affiliation: Takeda
name: Medical Director, Clinical Science
role: STUDY_DIRECTOR
References:
citation: 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.