drugset / Trial / NCT00397033
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Phase 3
Completed
316 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Janssen, LP · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to measure the effectiveness and assess the safety of two dosages of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.
Timeline
- Start
- 2006-11
- Primary completion
- 2008-02
- Completion
- 2008-02
Outcome
Met primary endpoint
paper Mean +/- SE PANSS total score (primary outcome) improved significantly with higher-dose paliperidone ER versus placebo (-32.4 +/- 2.1 versus -24.1 +/- 2.1; P = .003). PMID 20492853 ↗
registry Placebo vs Paliperidone Extended Release (ER) High Dose; p = 0.003; LS Means Difference -8.3 (95% CI -13.8 to -2.9) NCT00397033 ↗
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.
- Canuso CM, Lindenmayer JP, Kosik-Gonzalez C, Turkoz I, Carothers J, Bossie CA, Schooler NR. A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. J Clin Psychiatry. 2010 May;71(5):587-98. doi: 10.4088/JCP.09m05564yel.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paliperidone | Unknown | 6 mg | Oral |
| Subject | Paliperidone | Unknown | 12 mg | Oral |