NCT00210548

A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose-response study of patients who have a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) diagnosis of schizophrenia. The duration of the study is approximately 14 weeks, including a screening period of 1 week and a 13-week double-blind treatment period. Efficacy and safety will be evaluated periodically throughout the study. Samples for pharmacokinetic evaluation will be collected at designated time points, and a blood sample will be collected at baseline (before the start of double-blind treatment) for an optional pharmacogenomics (genetics) analysis. The hypothesis is that the 3 fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia. The effectiveness is measured primarily by the change in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), and secondarily, by the investigator's Clinical Global Impression of Severity (CGI-S) and by the investigator's evaluation of the patient on a Personal and Social Performance (PSP) Scale. Four injections of paliperidone palmitate 50, 100, or 150 milligrams equivalent administered in the gluteal muscle (buttocks). Injections will be given on Days 1, 8, 36, and 64 of the double-blind treatment period of the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	paliperidone palmitate

Timeline

• Start date: 2005-04-01
• Completion: 2006-06-01
• First posted: 2005-09-21
• Last updated: 2011-06-08