A secondary analysis of a phase 2 study investigating adjunctive pimavanserin for the treatment of patients with major depressive disorder (MDD) found that the add-on medication significantly improved insomnia and sleepiness in the patient population. Researchers presented their findings in a poster at Psych Congress 2020.
“This exploratory analysis supports further study of pimavanserin for adjunctive treatment of major depressive disorder, especially in patients with insomnia,” researchers wrote.
The poster focused on a secondary analysis of the CLARITY study, in which 207 patients with MDD and inadequate antidepressant response were initially randomized 3:1 to placebo or pimavanserin in addition to their current selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor for 5 weeks. Afterward, placebo nonresponders were randomized again to placebo or pimavanserin for another 5 weeks.
At baseline, 76% of patients assigned placebo and 85% assigned pimavanserin had a Hamilton Depression Rating Scale sleep disturbance score of 3 or higher. In those patients, researchers observed a significant improvement in sleep disturbance scores among those taking adjunctive pimavanserin, compared with placebo, at weeks 2, 3, and 4.
A significant drop from baseline on the Karolinska Sleepiness Scale was observed in participants taking pimavanserin, compared with placebo, at weeks 1 through 5. Among those with a baseline Karolinska Sleepiness Scale score of 6 or higher, researchers observed a significant improvement from baseline at weeks 1 through 5 on the Sheehan Disability Scale overall score and unproductive days subscore.
Fewer than 10% of patients took concomitant sedative/hypnotic medications, according to the poster. Acadia Pharmaceuticals Inc. sponsored the study.
Jha MK, Fava M, Freeman MP, et al. Effect of adjunctive pimavanserin on insomnia and function in patients with major depressive disorder: secondary analysis from CLARITY. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.