biostudies-literatureUnknown52(1)Bugarski-Kirola DAcadia Pharmaceuticals Inc<h4>Background and hypotheses</h4>Negative symptoms of schizophrenia (NSS) carry a substantial burden, and there are no treatments currently approved for NSS. The efficacy of pimavanserin, a selective 5-HT2A inverse agonist and antagonist, in treating NSS was assessed.<h4>Study design</h4>ADVANCE-2 was a phase 3, randomized, double-blind, placebo-controlled study of pimavanserin in patients with schizophrenia and predominantly negative symptoms. Patients were randomized (1:1) to receive pimavanserin (34 mg/day) or placebo alongside ongoing background antipsychotic medication. Eligible adults were aged 18-55 years and had access to a caregiver. The primary and key secondary endpoints were the change from baseline to week 26 in the Negative Symptom Assessment-16 (NSA-16) total score and ClinSchizophrenia bulletinsbaf034https://www.ebi.ac.uk/biostudies/studies/S-EPMC12809779biostudies-literatureA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as an Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE-2) in Patients With Predominant Negative Symptoms.PMC12809779Liu IYMarder SRBugarski-Kirola DArango CfalseA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as an Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE-2) in Patients With Predominant Negative Symptoms.<h4>Background and hypotheses</h4>Negative symptoms of schizophrenia (NSS) carry a substantial burden, and there are no treatments currently approved for NSS. The efficacy of pimavanserin, a selective 5-HT2A inverse agonist and antagonist, in treating NSS was assessed.<h4>Study design</h4>ADVANCE-2 was a phase 3, randomized, double-blind, placebo-controlled study of pimavanserin in patients with schizophrenia and predominantly negative symptoms. Patients were randomized (1:1) to receive pimavanserin (34 mg/day) or placebo alongside ongoing background antipsychotic medication. Eligible adults were aged 18-55 years and had access to a caregiver. The primary and key secondary endpoints were the change from baseline to week 26 in the Negative Symptom Assessment-16 (NSA-16) total score and Clin2026-01-01T00:00:00Z2026 Jan2026-06-06T15:59:33.906Z2026-06-02T03:10:54.034ZS-EPMC128097794018171510.1093/schbul/sbaf034