Status:
COMPLETED
Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder
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 the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of M...
Eligibility Criteria
Inclusion
- MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
- Moderate to severe depression
- Current MDE duration of at least 3 months
Exclusion
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- Any substance disorder within the previous 6 months
- Female patients of childbearing potential who are not using effective contraception
- Use of any psychoactive medication 2 weeks prior to screening and during the study
- Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
766 Patients enrolled
Trial Details
Trial ID
NCT00635219
Start Date
February 1 2008
End Date
April 1 2009
Last Update
February 11 2014
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