NCT03713658

A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities

A Pilot-Study in Rwandan Health Care Settings to Examine the Feasibility of a Large Pragmatic Clinical Study to Assess the Value of Paliperidone Palmitate in Rwanda

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility of conducting a study of oral risperidone followed by paliperidone palmitate for once monthly (PP1M) and paliperidone palmitate for every 3 months (PP3M) in rwandan healthcare facilities with mental healthcare capabilities.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Risperidone 3 mg	Participants will receive 3 mg oral risperidone tablets once daily for up to one Week.
DRUG	Paliperidone Palmitate 50 mg eq.	Participants will receive 50 mg eq. PP1M intramuscular injection for 17 Weeks.
DRUG	Paliperidone Palmitate 75 mg eq.	Participants will receive 75 mg eq. PP1M intramuscular injection for 17 Weeks.
DRUG	Paliperidone Palmitate 100 mg eq.	Participants will receive 100 mg eq. PP1M intramuscular injection for 17 Weeks.
DRUG	Paliperidone Palmitate 150 mg eq.	Participants will receive 150 mg eq. PP1M intramuscular injection for 17 Weeks.
DRUG	Paliperidone Palmitate 175 mg eq.	Participants will receive 175 mg eq. PP3M intramuscular injection for 24 Weeks.
DRUG	Paliperidone Palmitate 263 mg eq.	Participants will receive 263 mg eq. PP3M intramuscular injection for 24 Weeks.
DRUG	Paliperidone Palmitate 350 mg eq.	Participants will receive 350 mg eq. PP3M intramuscular injection for 24 Weeks.
DRUG	Paliperidone Palmitate 525 mg eq.	Participants will receive 525 mg eq. PP3M intramuscular injection for 24 Weeks.

Timeline

• Start date: 2018-10-18
• Primary completion: 2019-12-02
• Completion: 2019-12-02
• First posted: 2018-10-22
• Last updated: 2025-04-27

Locations

3 sites across 1 country: Rwanda