A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant. - SPD489-329

Shire Development Inc.0 个研究点目标入组 1,700 人开始时间: 2011年11月22日最近更新: 2014年3月10日

研究概览

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•· Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant adverse events in the antecedent study that would preclude exposure to SPD489.
•Subject was randomized as an inadequate responder in the antecedent study, or not randomized but continues to demonstrate residual depressive symptoms (MADRS total score of =5) at the end of the antecedent study, and in the Investigator’s opinion has the potential to benefit from adjunctive pharmacologic treatment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1665
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.
•Subject has any current co-morbid psychiatric disorder, either controlled with medications prohibited in this study or uncontrolled and associated with significant symptoms, which was not present or recognized at entry into the antecedent study and would have been exclusionary in the antecedent study.
•A new onset or known history of serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication, a history of moderate to severe hypertension or an average (of 3 readings) resting sitting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at study entry, 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.

发起方

Shire Development Inc.