Status:
COMPLETED
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
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 treat...
Eligibility Criteria
Inclusion
- \- Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A
Exclusion
- 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
- Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
535 Patients enrolled
Trial Details
Trial ID
NCT00694304
Start Date
May 1 2008
End Date
April 1 2010
Last Update
April 1 2014
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