Status:
COMPLETED
Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
Lead Sponsor:
Takeda
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
Detailed Description
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in p...
Eligibility Criteria
Inclusion
- Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
- The reported duration of the current major depressive episode is at least 3 months.
Exclusion
- Has 1 or more the following:
- Any current psychiatric disorder other than major depressive 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 disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- Any Axis II disorder that might compromise the study.
- Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
- The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- Has received electroconvulsive therapy within 6 months prior to Screening.
- Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
611 Patients enrolled
Trial Details
Trial ID
NCT00672620
Start Date
April 1 2008
End Date
December 1 2008
Last Update
December 18 2013
Active Locations (38)
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1
Beverly Hills, California, United States
2
Irvine, California, United States
3
Santa Ana, California, United States
4
Torrance, California, United States