Primary Outcome Measures:
- The least squares mean change from Baseline in the Hamilton Anxiety Scale total score. [ Time Frame: Week 8. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 Hamilton Anxiety Scale 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-Global Improvement. [ Time Frame: At All Visits ] [ Designated as safety issue: No ]
- The least squares mean change from Baseline in Clinical Global Impression Scale-Severity of Illness. [ Time Frame: At All Visits ] [ Designated as safety issue: No ]
- The least squares mean change from Baseline in Hospital Anxiety and Depression anxiety subscale [ Time Frame: Weeks 1, 4 and 8. ] [ 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: Final Visit ] [ Designated as safety issue: No ]
Subjects participating in this study will be randomly assigned to receive either 2.5 mg or 10 mg of Lu AA21004 or a placebo once daily for an eight week treatment period.
Subjects 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