Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.

Summary

The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

Timeline

Start

2006-12

Primary completion

2008-06

Completion

2008-06

Outcome

Mixed primary results

registry Placebo vs Paliperidone Extended-Release (ER); p = 0.774; LS Mean Difference 0.5 (95% CI -2.7 to 3.7); ANOVA NCT00412373 ↗

registry Placebo vs Paliperidone Extended-Release (ER); p <0.001; LS Mean Difference -9.4 (95% CI -13.8 to -4.9); ANCOVA NCT00412373 ↗

Publications

• Alphs L, Fu DJ, Turkoz I. Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother. 2016;17(6):871-83. doi: 10.1517/14656566.2016.1161029. Epub 2016 Mar 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paliperidone	Unknown	3 mg	Oral
Subject	Paliperidone	Unknown	6 mg	Oral
Subject	Paliperidone	Unknown	9 mg	Oral
Subject	Paliperidone	Unknown	12 mg	Oral

Indications