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

NCT03713658 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-04-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2019-12-02
Completion
2019-12-02

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03713658 on ClinicalTrials.gov