Status:
TERMINATED
Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.
Detailed Description
Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or mor...
Eligibility Criteria
Inclusion
- In- and out-patients with moderate to severe Major Depressive Disorder
- Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (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
- Females of childbearing potential and not using adequate contraception
- Use of any psychoactive medication within 2 weeks before randomisation and during the study
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00766870
Start Date
September 1 2008
End Date
February 1 2009
Last Update
September 29 2010
Active Locations (1)
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1
CA009
Mississauga, Ontario, Canada, ON L5M 4N4