Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia

Phase 2 Completed 250 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.

Timeline

Start: 2003-10
Primary completion: —
Completion: 2004-07

Outcome

Met primary endpoint

paper Mean (s.d.) PANSS total scores showed significant improvement at endpoint (primary measure) PMID 19941696 ↗

paper vs. placebo [6.2 (18.3)] (p0.001, each dose vs. placebo). PMID 19941696 ↗

Publications

Kramer M, Litman R, Hough D, Lane R, Lim P, Liu Y, Eerdekens M. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol. 2010 Jun;13(5):635-47. doi: 10.1017/S1461145709990988. Epub 2009 Nov 27.

Drugs

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