Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia
Summary
The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. in the deltoid muscle followed by either deltoid or gluteal injections for a total of 13 weeks of treatment as compared with placebo in patients with schizophrenia.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-03
- Completion
- 2008-03
Outcome
Met primary endpoint
registry analysis (superiority or other test); Paliperidone Palmitate 150 mg eq. vs Placebo; p <0.001; Difference in least-squares means -9.8 (95% CI -13.71 to -5.85); ANCOVA; NCT00590577 ↗
registry analysis (superiority or other test); Paliperidone Palmitate 100 mg eq. vs Placebo; p <0.001; Difference in least-squares means -8.7 (95% CI -12.62 to -4.78); ANCOVA; NCT00590577 ↗
registry analysis (superiority or other test); Paliperidone Palmitate 25 mg eq. vs Placebo; p = 0.034; Difference in least-squares means -5.1 (95% CI -9.01 to -1.10); ANCOVA; NCT00590577 ↗
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.
- Bossie CA, Sliwa JK, Ma YW, Fu DJ, Alphs L. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial. BMC Psychiatry. 2011 May 10;11:79. doi: 10.1186/1471-244X-11-79.
- Alphs L, Bossie CA, Sliwa JK, Ma YW, Turner N. Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial. Ann Gen Psychiatry. 2011 Apr 11;10(1):12. doi: 10.1186/1744-859X-10-12.
- Pandina GJ, Lindenmayer JP, Lull J, Lim P, Gopal S, Herben V, Kusumakar V, Yuen E, Palumbo J. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010 Jun;30(3):235-44. doi: 10.1097/JCP.0b013e3181dd3103.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | paliperidone palmitate | Unknown | 25 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 100 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 150 mg | Intramuscular |