Status:
COMPLETED
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 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
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder.
Eligibility Criteria
Inclusion
- The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)
- The patient has a MADRS total score \>=26
- The patient has a CGI-S score \>=4
- The patient has had the current episode of MDE for \>3 months
Exclusion
- Any current anxiety psychiatric disorder as defined in the DSM-IV TR
- Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR
- Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR
- Use of any psychoactive medication 2 weeks prior to screening and during the study
- The patient is at significant risk of suicide or has a score \>=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit
- Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT01140906
Start Date
May 1 2010
Last Update
February 11 2014
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