Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Long-term, Open-label Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder|
- Number of Patients With Adverse Events (AEs) [ Time Frame: Up to 52 weeks and a 4-week safety follow-up period ] [ Designated as safety issue: Yes ]
- Percentage of Patients Who Withdrew Due to Intolerance to Treatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
- Change From Baseline in MADRS Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
- Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
- Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Drug: Vortioxetine (Lu AA21004)
5 or 10 mg/day; tablets; orally
Other Name: Brintellix