ACADIA initiates Phase II Pimavanserin trial for MDD
ACADIA Pharmaceuticals announced the initiation of CLARITY, a Phase II study to evaluate pimavanserin for adjunctive treatment in patients with major depressive disorder who have an inadequate response to first-line therapies for clinical depression. Pimavanserin is a selective serotonin inverse agonist preferentially targeting 5-HT2A receptors that may play a role in depression. CLARITY is a Phase II, 10-week, randomized, double-blind, placebo-controlled, multi-center study designed to examine the efficacy and safety of adjunctive use of pimavanserin in patients with major depressive disorder who have an inadequate response to standard antidepressant therapy with either a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor. Approximately 188 patients will be randomized to receive either 34 mg of pimavanserin or placebo, orally, once daily, in addition to their ongoing antidepressant for 10 weeks. The primary endpoint of the study is the change from baseline on the Hamilton Depression Rating Scale total score.