NCT04072575

A Study of Paliperidone Palmitate 6-Month Formulation

Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 \[milligram\] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	PP6M injection Dose 1	Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.
DRUG	PP6M injection Dose 2	Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.

Timeline

• Start date: 2019-09-19
• Primary completion: 2022-05-03
• Completion: 2022-05-03
• First posted: 2019-08-28
• Last updated: 2025-04-29
• Results posted: 2023-05-31

Locations

30 sites across 6 countries: Argentina, Hong Kong, Italy, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study