Status:
COMPLETED
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total sc...
Eligibility Criteria
Inclusion
- Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:
- Reported duration of the current episode of at least 4 weeks
- MADRS total score \>=26
- At least one previous MDE before the age of 60 years
Exclusion
- Mini Mental State Exam (MMSE) \<24
- Any current anxiety disorder as defined in the DSM-IV-TR
- Current or past 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
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
- Presence or history of a clinically significant neurological disorder (including epilepsy)
- Neurodegenerative disorder (Alzheimer's disease, Parkinson disease, multiple sclerosis, Huntington disease, etc)
- Any Axis II disorder that might compromise the study
- Significant risk of suicide according to the investigator's opinion, or has a score \>=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months
- Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT00811252
Start Date
January 1 2009
End Date
March 1 2010
Last Update
January 29 2014
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