Pimavanserin – Major Depressive Disorder
Pimavanserin is a proprietary small molecule that we have advanced to Phase II development for major depressive disorder (MDD). Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. Its distinct mechanism of action targets serotonergic 5-HT2A receptors that may play a role in depression.
About Major Depressive Disorder
According to the National Institute of Mental Health, MDD affects approximately 16 million adults in the United States and is the leading cause of disability in people age 15 to 44. MDD is a condition characterized by depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities for more than two weeks, as well as impaired social, occupational or other important functioning. The majority of people who suffer from MDD do not respond to initial antidepressant therapy.
We are currently conducting a Phase II, 10-week, randomized, double-blind, placebo-controlled, multi-center study, referred to as the CLARITY study. CLARITY is 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 (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). 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 (HAM-D) total score.