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news.ACADIA Pharmaceuticals has started a Phase II study dubbed CLARITY to evaluate pimavanserin for adjunctive treatment in patients with major depressive disorder (MDD) who have an inadequate response to first-line therapies for clinical depression.
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Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors that may play a role in depression.
Massachusetts General Hospital (MGH) Department of Psychiatry executive vice chair and Harvard Medical School Clinical & Translational Research associate dean Professor Maurizio Fava, M.D. said: “Major depressive disorder affects millions of people in the United States every year and many do not respond adequately to currently available treatments.
“With its highly selective mechanism of action, pimavanserin may provide a new approach to the adjunctive treatment of patients with major depressive disorder and may represent an opportunity to improve clinical outcomes in these patients.”
ACADIA executive vice president, Research and Development head said: “We are committed to the development of pimavanserin in additional CNS disorders that are underserved by currently available therapies and represent a significant unmet medical need. Inadequate response to current antidepressants is one such condition.
“We are gratified to be able to leverage the vast knowledge and expertise of our colleagues at MGH and conduct this study in collaboration with the MGH Clinical Trials Network & Institute.”
About CLARITY
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 (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.
About Major Depressive Disorder (MDD)
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 for ages 15-44. 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.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in depression. Pimavanserin is being evaluated in an extensive clinical development program by ACADIA across multiple indications.
Pimavanserin (34 mg) was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID. NUPLAZID is not approved for the adjunctive treatment of patients with major depressive disorder.