Acadia presents Phase 2 CLARITY results for Pimavanserin
Acadia Pharmaceuticals presented data from its Phase 2 CLARITY study, which evaluated the efficacy, safety, and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder at the 2019 American Psychiatric Association Annual Meeting. The Phase 2 CLARITY study was a 10-week, randomized, double-blind, placebo-controlled, multi-center, two-stage sequential parallel comparison design study that evaluated the efficacy, safety, and tolerability of pimavanserin. Pimavanserin was administered as an adjunctive treatment in patients with MDD who had an inadequate response to a stable dose of standard antidepressant therapy with either a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor. The study randomized 207 patients across 27 clinical research centers in the U.S. and was conducted in collaboration with the Massachusetts General Hospital Clinical Trials Network and Institute. In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing the 17-item Hamilton Depression Rating Scale total score compared to placebo. On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score. Positive results were also observed for seven other secondary endpoints, including improvement in daytime sleepiness as measured by the Karolinska Sleepiness Scale and improvement in sexual function as measured by the Massachusetts General Hospital Sexual Functioning Index. On April 25, ACADIA announced it had initiated its Phase 3 CLARITY program for pimavanserin as an adjunctive treatment for MDD. The CLARITY-2 study will be based in the U.S. and has already initiated enrollment and the CLARITY-3 study will be based outside the U.S. and will initiate enrollment in the upcoming months. Both studies are six-week, parallel-designed, randomized, double-blind, placebo-controlled, multi-center studies designed to evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with MDD who have an inadequate response to standard antidepressant therapy with either a SSRI or a SNRI.