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Alkermes advancing new trial design to eliminate placebo problems in depression
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New designs in depression
Monday, November 18, 2013
An innovative clinical trial design developed by a pair of
academics is helping drug companies eliminate the placebo response that has
dogged development of drugs for depression. Next year, Alkermes
plc will become the first sponsor to see whether a sequential parallel
comparison design can replicate a Phase II success in a Phase III trial.
In October, Alkermes received
Fast Track designation for ALKS 5461 as an adjunctive therapy to treat major
depressive disorder (MDD) and said it would begin a Phase III study in 2014
using sequential parallel comparison design (SPCD).
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