Adherence to Background Antipsychotic and Pimavanserin in Patients with Schizophrenia: Post Hoc Analyses from the ENHANCE and ADVANCE Studies.

"Disclosure Dragana Bugarski-Kirola, Mona Darwish, and I-Yuan Liu are employees of and stockholders in Acadia Pharmaceuticals Inc. Brandon Abbs, Daryl DeKarske, and Ramzey Odetalla are former employees of Acadia Pharmaceuticals Inc. The authors report no other conflicts of interest in this work."

"The ENHANCE and ADVANCE studies and medical writing and editing support for the development of this manuscript were funded by Acadia Pharmaceuticals Inc."

"The design and methodology of the ENHANCE and ADVANCE studies have been reported previously., Study protocols were reviewed and approved by independent ethics committees or institutional review boards at each study site. Both studies were conducted in accordance with the principles of Good Clinical Practice derived from the Declaration of Helsinki, and in accordance with local regulations and International Council of Harmonization guidelines. All patients provided written informed consent prior to enrolling in the study. This retrospective analysis utilized anonymized patient data to maintain patient privacy. Both studies were registered with ClinicalTrials.gov (Identifiers: NCT02970292 and NCT02970305). Patients enrolled in ENHANCE and ADVANCE were randomly assigned to receive either pimavanserin (flexible dosing of 10, 20, or 34 mg) or placebo added to ongoing antipsychotic therapy. Several eligibility and testing requirements were specifically included in the design of both studies to enable the assessment of treatment adherence among participants (). Figure 1Study design. aStarting dose of pimavanserin or placebo was 20 mg daily and could be adjusted up to 34 mg or down to 10 mg daily after week 1 (ENHANCE) or week 2 (ADVANCE) based on investigator discretion; after week 3 (ENHANCE) and week 8 (ADVANCE), no changes to the dose of the study drugs were made. bSecond-generation antipsychotic agents included aripiprazole (oral or long-acting injection), asenapine, brexpiprazole, cariprazine, lurasidone, olanzapine, and risperidone (oral or long-acting injection).Abbreviations: BL, baseline; CGI-S, Clinical Global Impression-Severity; ET, early termination; NSA-16, 16-item Negative Symptoms Assessment; PANSS, Positive and Negative Syndrome Scale; PSP, Personal and Social Performance Scale."