Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
This study has been completed.
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
First received: March 24, 2011
Last updated: December 23, 2013
Last verified: December 2013
To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- Number of Patients With Adverse Events (AEs) [ Time Frame: Baseline to end of the 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 ]
Secondary Outcome Measures:
- 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 CGI-S Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
- Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. 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: Baseline from lead-in study 13267A (NCT01140906) and Week 52 ] [ Designated as safety issue: No ]
- Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
- SDS Total Score After 52 Weeks of Treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.
- ASEX Total Score After 52 Weeks of Treatment [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction.
- Risk of Suicidality Using C-SSRS Scores [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period.
|Study Start Date:||April 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Drug: Vortioxetine (Lu AA21004)
15 or 20 mg/day; tablets; orally
Other Name: Brintellix
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