Status:
COMPLETED
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute 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 this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).
Eligibility Criteria
Inclusion
- MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
- Current MDE duration of at least 3 months and less than 12 months
- The patient has a MADRS total score \>=30
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 :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT00839423
Start Date
August 1 2006
End Date
September 1 2007
Last Update
May 13 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.