Clinical trial NCT00731120: Study of Efficacy and Safety 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 2 Doses 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: 2008-08-08
Enrollment: 457
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 evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Detailed description: Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.

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.

Eligibility criteria: Inclusion Criteria:

* Has a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
* 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:

* 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 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.

Primary outcomes:
measure: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
timeFrame: Baseline and Weeks 1, 2, 4 and 6
measure: Percentage of Responders in HAM-A Total Score at Week 8
timeFrame: Baseline and Week 8
measure: Percentage of Participants in HAM-A Remission at Week 8
timeFrame: Week 8
measure: Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed
timeFrame: Baseline and Weeks 1, 2, 4, 6 and 8.
measure: Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
timeFrame: Baseline and Weeks 1, 2, 4, 6 and 8.
measure: Change From Baseline in Hospital Anxiety and Depression (HAD) Scales
timeFrame: Baseline and Weeks 1, 4 and 8.
measure: Change From Baseline in Sheehan Disability Scale (SDS) at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in 36-item Short-form Health Survey (SF-36)
timeFrame: Baseline and Week 8
measure: Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Orange
country: United States
state: California
city: Redlands
country: United States
state: California
city: Cromwell
country: United States
state: Connecticut
city: Norwich
country: United States
state: Connecticut
city: Hockessin
country: United States
state: Delaware
city: Fort Myers
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lady Lake
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Libertyville
country: United States
state: Illinois
city: Valparaiso
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Prairie Village
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Braintree
country: United States
state: Massachusetts
city: Pittsfield
country: United States
state: Massachusetts
city: St Louis
country: United States
state: Missouri
city: Cherry Hill
country: United States
state: New Jersey
city: Fresh Meadows
country: United States
state: New York
city: New York
country: United States
state: New York
city: Olean
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Emmaus
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: North Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Midlothian
country: United States
state: Virginia
city: Waukesha
country: United States
state: Wisconsin
Study officials:
affiliation: Takeda
name: Medical Director, Clinical Science
role: STUDY_DIRECTOR
References:
citation: 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.