Status:
COMPLETED
Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The primary objective of this study was to compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment. The study hypot...
Detailed Description
Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentra...
Eligibility Criteria
Inclusion
- The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR criteria (classification code 296.xx; current episode assessed using the MINI)
- The patient has a MADRS total score \>=26 and a CGI-S score \>=4 at the Baseline Visit
Exclusion
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- 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 :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT01148472
Start Date
September 1 2005
End Date
November 1 2006
Last Update
November 8 2016
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