Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
2 other identifiers
interventional
535
0 countries
N/A
Brief Summary
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 8-week acute treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 major-depressive-disorder
Started May 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 6, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
April 1, 2014
CompletedApril 1, 2014
February 1, 2014
1.8 years
June 6, 2008
October 28, 2013
February 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients With Adverse Events (AEs)
Baseline to end of the 4-week safety follow-up period
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Baseline to Week 52
Secondary Outcomes (8)
Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
Baseline and Week 52
Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment
Baseline and Week 52
Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment
Baseline and Week 52
Change From Baseline in CGI-S Score After 52 Weeks of Treatment
Baseline and Week 52
Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
Week 52
- +3 more secondary outcomes
Study Arms (1)
Vortioxetine
EXPERIMENTALInterventions
2.5, 5, or 10 mg/day; tablets; orally
Eligibility Criteria
You may qualify if:
- \- Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A
You may not qualify if:
- Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)
- Female patients of childbearing potential who are not using effective contraception
- Use of any psychoactive medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Related Publications (1)
Baldwin DS, Hansen T, Florea I. Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr Med Res Opin. 2012 Oct;28(10):1717-24. doi: 10.1185/03007995.2012.725035. Epub 2012 Sep 17.
PMID: 22978748RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- H. Lundbeck A/S
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2008
First Posted
June 10, 2008
Study Start
May 1, 2008
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
April 1, 2014
Results First Posted
April 1, 2014
Record last verified: 2014-02