NCT04000009

Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.

Conditions

• Adjunctive Treatment of Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Pimavanserin	Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily

Timeline

• Start date: 2019-06-06
• Primary completion: 2021-02-22
• Completion: 2021-02-22
• First posted: 2019-06-27
• Last updated: 2022-04-05
• Results posted: 2022-04-05

Locations

71 sites across 9 countries: United States, Finland, Poland, Russia, Serbia, Slovakia, South Africa, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study