Status:
COMPLETED
Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Lead Sponsor:
Takeda
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-76 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the long-term 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 people who have major depressive disorder (MDD). This study looked at MDD relief in p...
Eligibility Criteria
Inclusion
- Has completed the double blind treatment period of either study Lu AA21004\_304 (NCT00672620) or LuAA21004\_305 (NCT00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
- 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 (classification code 296.xx) at entry into the prior Lu AA21004\_304 or Lu AA21004\_305 study.
Exclusion
- In addition to meeting the exclusion criteria for studies Lu AA21004\_304 or Lu AA21004\_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:
- Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
- The participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale.
- The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
- Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
- Has used/uses disallowed concomitant medication.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
836 Patients enrolled
Trial Details
Trial ID
NCT00707980
Start Date
June 1 2008
End Date
August 1 2010
Last Update
December 13 2013
Active Locations (92)
Enter a location and click search to find clinical trials sorted by distance.
1
Beverly Hills, California, United States
2
Irvine, California, United States
3
Santa Ana, California, United States
4
Torrance, California, United States