An Efficacy and Safety Study of Lu AA21004 in Treating Generalized Anxiety Disorder
The purpose of this study is to determine the safety and efficacy of Lu AA21004, once daily (QD), in treating Generalized Anxiety Disorder.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- The least squares mean change from Baseline in the Hamilton Anxiety Scale total score after 8 weeks of treatment. [ Time Frame: Week: 8 ] [ Designated as safety issue: No ]
- The least squares mean change from Baseline in Hamilton Anxiety Scale total score at each week assessed. [ Time Frame: At all visits. ] [ Designated as safety issue: No ]
- Response rates at Week 8, with response defined as a ≥50% decrease in the HAM-A total score from Baseline. [ Time Frame: Week: 8 ] [ Designated as safety issue: No ]
- Remission rates at Week 8, with remission defined as a Hamilton Anxiety Scale total score ≤7. [ Time Frame: Week: 8 ] [ Designated as safety issue: No ]
- The least squares mean change from Baseline in Clinical Global Impression Scale-Severity of Illness and Hospital Anxiety and Depression anxiety subscale. [ Time Frame: At all visits. ] [ Designated as safety issue: No ]
- The least squares mean change from Baseline in Clinical Global Impression Scale-Global Improvement. [ Time Frame: At all visits. ] [ Designated as safety issue: No ]
- Sheehan Disability Scale. [ Time Frame: Weeks: 1, 2, 4 and 8. ] [ Designated as safety issue: No ]
- Medical Outcomes Study 36-Item Short-Form Health Survey. [ Time Frame: Weeks: 2, 4 and 8. ] [ Designated as safety issue: No ]
- Health care resource utilization as assessed by the Health Economic Assessment Questionnaire [ Time Frame: Week: 8. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Experimental: Lu AA21004 5 mg QD||
Drug: Lu AA21004
Lu AA21004 5 mg, tablets, orally, once daily for up to 8 weeks.
|Placebo Comparator: Placebo QD||
Lu AA21004 placebo-matching tablets, orally, once daily for up to 8 weeks.
Generalized anxiety disorder is associated with considerable personal stress as well as substantial social and functional impairment. It is characterized by excessive anxiety and uncontrollable worry that persist for longer than 6 months. Typically these worries are related to activities that are common to daily life events. Furthermore, patients with generalized anxiety disorder suffer from at least 3 of the following symptoms: restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and impaired sleep cycle. Patients with generalized anxiety disorder also suffer from many somatic symptoms such as palpitation, fast pulse, sweating, dyspnea, pain, nausea, dry mouth, and dizziness. Generalized anxiety disorder affects about 6.8 million American adults, including twice as many women as men. The disorder develops gradually and can begin at any point in the life cycle, although years of highest risk are between childhood and middle age. There is evidence that genes play a modest role in the disorder. About 12% of the patients in anxiety disorder clinics have generalized anxiety disorder, making it the most common diagnosis. In comparison with other anxiety disorders, generalized anxiety disorder is 4 times more prevalent than panic disorder and 3 times more prevalent than simple phobia. An estimate one-third of people with generalized anxiety disorder have no other comorbid diagnosis.
Lu AA21004 is a compound under development by Takeda Pharmaceutical Company Limited and H. Lundbeck A/S for the treatment of generalized anxiety disorder. Lu AA21004 combines serotonin enhancement with 5-hydroxytryptamine-1A partial agonism and affinity for the 5-hydroxytryptamine-3 receptor.
This aim of this phase 3 study is to investigate the efficacy and safety of a fixed dose of 5 mg Lu AA21004 QD in the treatment of generalized anxiety disorder.
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|Study Director:||Sr. Medical Director||Takeda Global Research & Development Center, Inc.|