Status:
COMPLETED
Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 treat...
Eligibility Criteria
Inclusion
- \- Patients who completed 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period
Exclusion
- 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
- Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00761306
Start Date
June 1 2007
End Date
October 1 2008
Last Update
January 29 2014
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