drugset / Trial / NCT00589914
Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.
Timeline
- Start
- 2007-03
- Primary completion
- 2009-06
- Completion
- 2009-06
Publications
- Alphs L, Bossie CA, Fu DJ, Ma YW, Kern Sliwa J. Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother. 2014 May;15(7):1029-42. doi: 10.1517/14656566.2014.909409.
- Fu DJ, Bossie CA, Sliwa JK, Ma YW, Alphs L. Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Int Clin Psychopharmacol. 2014 Jan;29(1):45-55. doi: 10.1097/YIC.0000000000000006.
- Fu DJ, Bossie CA, Kern Sliwa J, Ma YW, Alphs L. Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clin Schizophr Relat Psychoses. 2014 Jul;8(2):101-9, 109A.
- Pandina G, Lane R, Gopal S, Gassmann-Mayer C, Hough D, Remmerie B, Simpson G. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):218-26. doi: 10.1016/j.pnpbp.2010.11.008. Epub 2010 Nov 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paliperidone | Unknown | 50 mg | Intramuscular |
| Subject | Paliperidone | Unknown | 100 mg | Intramuscular |
| Subject | Paliperidone | Unknown | 150 mg | Intramuscular |
| Comparator | Risperidone | Other / unclassified | 25 mg | Intramuscular |
| Comparator | Risperidone | Other / unclassified | 37.5 mg | Intramuscular |
| Comparator | Risperidone | Other / unclassified | 50 mg | Intramuscular |