A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
Summary
This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
Timeline
- Start
- 2010-09
- Primary completion
- 2013-10
- Completion
- 2013-10
Outcome
Met primary endpoint
paper Paliperidone monthly significantly delayed time to relapse for psychotic, depressive, and manic symptoms compared with placebo (P < .001, log-rank test). PMID 25562685 ↗
paper Overall relapse rates were 33.5% for placebo and 15.2% for paliperidone monthly. PMID 25562685 ↗
release “Study Found INVEGA® SUSTENNA® (paliperidone palmitate) Once -Monthly Long-Acting Therapy Delayed Time to and Reduced Risk of Relapse in Individuals with Schizoaffective” jnj.com ↗
release “The trial found INVEGA® SUSTENNA® met its primary endpoint of delayed time to and reduced risk of relapse compared to” jnj.com ↗
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.
- Fu DJ, Turkoz I, Simonson RB, Walling DP, Schooler NR, Lindenmayer JP, Canuso CM, Alphs L. Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder. J Clin Psychiatry. 2015 Mar;76(3):253-62. doi: 10.4088/JCP.14m09416.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paliperidone | Unknown | 78 mg | Intramuscular |
| Subject | Paliperidone | Unknown | 117 mg | Intramuscular |
| Subject | Paliperidone | Unknown | 156 mg | Intramuscular |
| Subject | Paliperidone | Unknown | 234 mg | Intramuscular |