Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
A Long-term, Open-label Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
2 other identifiers
interventional
74
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 6-week acute treatment in study NCT00839423 / 11492A.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 major-depressive-disorder
Started Jun 2007
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
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 29, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
December 17, 2013
CompletedJanuary 29, 2014
December 1, 2013
1.3 years
September 26, 2008
October 28, 2013
December 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients With Adverse Events (AEs)
Up to 52 weeks and a 4-week safety follow-up period
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Baseline to Week 52
Secondary Outcomes (4)
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
Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
Week 52
Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
Week 52
Study Arms (1)
Vortioxetine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- \- Patients who completed 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period
You may not qualify if:
- Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, 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
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 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 29, 2008
Study Start
June 1, 2007
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
January 29, 2014
Results First Posted
December 17, 2013
Record last verified: 2013-12