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

Summary

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

Timeline

Start

2005-04

Primary completion

—

Completion

2006-06

Outcome

Met primary endpoint

paper The change from baseline in Positive and Negative Syndrome Scale total score at endpoint showed improvement PMID 20389255 ↗

paper significant only in the 100 mg eq. group (P=0.019). PMID 20389255 ↗

Publications

• Gopal S, Hough DW, Xu H, Lull JM, Gassmann-Mayer C, Remmerie BM, Eerdekens MH, Brown DW. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010 Sep;25(5):247-56. doi: 10.1097/YIC.0b013e32833948fa.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	paliperidone palmitate	Unknown	50 mg	Intramuscular
Subject	paliperidone palmitate	Unknown	100 mg	Intramuscular
Subject	paliperidone palmitate	Unknown	150 mg	Intramuscular

Indications