NCT03713658View on ClinicalTrials.gov

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

PHASE4CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

October 18, 2018

Primary Completion Date

December 2, 2019

Study Completion Date

December 2, 2019

Conditions
Schizophrenia
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.

Trial Locations (3)

10

Kibungo Referral Hospital, Ngoma District

57

Ruhengeri Referral Hospital, Public Hospital, Musanze District

423

CARAES Ndera Neuro-Psychiatric Hospital, Kigali

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03713658 - A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities | Biotech Hunter | Biotech Hunter