Status:
TERMINATED
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
Lead Sponsor:
Shire
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if th...
Eligibility Criteria
Inclusion
- Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.
Exclusion
- Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol
Key Trial Info
Start Date :
February 27 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2014
Estimated Enrollment :
1570 Patients enrolled
Trial Details
Trial ID
NCT01436175
Start Date
February 27 2012
End Date
March 27 2014
Last Update
June 14 2021
Active Locations (212)
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1
Birmingham Research Group
Birmingham, Alabama, United States, 35216
2
ResearchOne, Inc.
Scottsdale, Arizona, United States, 85251
3
Arkansas Psychiatric Clinical Research Trials, P.A.
Little Rock, Arkansas, United States, 72223
4
South Coast Clinical Trials, Inc.
Anaheim, California, United States, 92804