Status:
COMPLETED
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
Lead Sponsor:
Takeda
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-77 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the long-term safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder.
Detailed Description
Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder (MDD) is among the most important causes of disabi...
Eligibility Criteria
Inclusion
- Has completed either study LuAA21004\_315 ( NCT01153009), LuAA21004\_316 (NCT01163266), or LuAA21004\_317 (NCT01179516) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the Week 8 \[Lu AA21004\_317\] or Week 10 \[Lu AA21004\_315 or Lu AA21004\_316\] assessment of the preceding protocol).
- Suffers from a recurrent major depressive episode) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) at entry into the prior study.
- Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this participant according to the opinion of the investigator.
- Females of childbearing potential who are sexually active with a nonsterilized male partner agree to routinely use adequate contraception throughout the duration of the study.
Exclusion
- Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
- In the investigator's clinical judgment, 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 (MADRS).
- 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 :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
1075 Patients enrolled
Trial Details
Trial ID
NCT01152996
Start Date
September 1 2010
End Date
May 1 2013
Last Update
May 28 2014
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