An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Schizophrenia
Interventions
DRUG

Paliperidone

Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) up to 12 mg once daily for 8 weeks in Run-in or Stabilization phase, and 3-12 mg fixed dose oral tablet will be administered in DB phase. Participants who will enter open-label extension phase will receive paliperidone as 3-12 mg per day.

DRUG

Placebo

Participants who transitioned from run-in or stabilization phase will receive matching placebo to paliperidone ER once daily during DB phase of the study.

Trial Locations (14)

Unknown

Baoding

Beijing

Changsha

Chengdu

Guangzhou

Harbin

Kunming

Nanjing

Shanghai

Taiyuan

Tianjin

Wuhan

Xi'an

Xinxiang

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01662310 - An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia | Biotech Hunter | Biotech Hunter