Overview

Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder

Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
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 hypothesis was that there were clinically important differences between the two drugs in terms of efficacy and adverse event profiles.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
H. Lundbeck A/S
Treatments:
Citalopram
Dexetimide
Duloxetine Hydrochloride
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.