NCT03121586

Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 995 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Pimavanserin	Pimavanserin 10 mg, tablet, taken as one 10 mg tablets, once daily by mouth, OR Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth

Timeline

• Start date: 2017-01-01
• Primary completion: 2024-04-30
• Completion: 2024-05-30
• First posted: 2017-04-20
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

161 sites across 14 countries: United States, Argentina, Bulgaria, Canada, Croatia, Czechia, Hungary, Italy, Lithuania, Poland, Russia, Serbia, Spain, Ukraine

Regulatory

• FDA-regulated drug study