It’s Halloween, so pardon the bad pun. Acadia Pharmaceuticals (ACAD) is using black magic to dress up a failed depression drug clinical trial into something that resembles a positive result. Don’t be frightened, it’s all make-believe.
I’ll try to keep an explanation as simple as possible. Acadia conducted a Phase 2 clinical trial of its drug pimavanserin in patients with treatment-resistant depression. The study relied on what is known as a sequential parallel comparison design (SPCD) meant to counteract the large placebo effect often seen in depression drug studies. This kind of study is done in two stages, each lasting five weeks.
the company stated that “weighted average results of Stage 1 and Stage 2” was the study’s “primary endpoint”. so how is it possible that the study was able to be approved and designed using SPCD as an operationalization method and “weighted average results of Stage 1 and Stage 2” as a primary endpoint?
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