ACADIA Pharmaceuticals (Nasdaq:ACAD) today announced positive top-line results from CLARITY, a randomized, double-blind, placebo-controlled, multi-center, sequential parallel comparison design (SPCD) study in major depressive disorder (MDD). As quoted in the press release: In the study, 207 adult patients with a confirmed inadequate response to existing first-line SSRI or SNRI therapy for MDD received adjunctive treatment …

As quoted in the press release:

In the study, 207 adult patients with a confirmed inadequate response to existing first-line SSRI or SNRI therapy for MDD received adjunctive treatment of either 34 mg pimavanserin or placebo in addition to pre-existing first-line therapy for five weeks (Stage 1). Those patients who did not show a response to placebo in Stage 1 were re-randomized to receive either pimavanserin or placebo for a second five-week treatment period (Stage 2).
In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing 17-item Hamilton Depression Rating Scale (HAMD-17) total score compared to placebo (p=0.039). In addition, in Stage 1 (n=207) patients on pimavanserin demonstrated a highly significant improvement in HAMD-17 (p=0.0003). Importantly, this group of patients saw a benefit over placebo in the first week of treatment (p=0.0365). Stage 2 (n=58) results did not demonstrate significant separation in this small set of placebo non-responders.

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