NCT04531982

Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Pimavanserin	Pimavanserin 34 mg, taken as two blinded 17 mg tablets once daily by mouth
DRUG	Placebo	Placebo, taken as two blinded tablets once daily by mouth

Timeline

• Start date: 2020-08-05
• Primary completion: 2024-01-25
• Completion: 2024-02-19
• First posted: 2020-08-31
• Last updated: 2025-08-22
• Results posted: 2025-04-01

Locations

102 sites across 12 countries: Argentina, Bulgaria, Croatia, Czechia, Hungary, Italy, Lithuania, Poland, Russia, Serbia, Spain, Ukraine

Regulatory

• FDA-regulated drug study