Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: Pooled data from three 6-week, placebo-controlled studies

Journal of Clinical Psychiatry

Volumn 69, Issue 5, 2008, Pages 817-829

  Meltzer, Herbert Y ^a,d,e   Bobo, William V ^a   Nuamah, Isaac F ^b   Lane, Rosanne ^b   Hough, David ^b   Kramer, Michelle ^b   Eerdekens, Marielle ^c  

^a VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^b JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^c JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^d BRISTOL MYERS SQUIBB   (United States)

^e Psychiatric Hospital at Vanderbilt   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; LORAZEPAM; OLANZAPINE; PALIPERIDONE; PLACEBO; PROLACTIN;

ABNORMAL INVOLUNTARY MOVEMENT SCALE; ADULT; AGITATION; AKATHISIA; AMENORRHEA; ANXIETY; ARTICLE; BARNES AKATHISIA RATING SCALE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSKINESIA; DYSPEPSIA; DYSTONIA; ELECTROCARDIOGRAPHY; ESOPHAGUS OBSTRUCTION; EXTRAPYRAMIDAL SYMPTOM; EXTRAPYRAMIDAL SYNDROME; FEMALE; GALACTORRHEA; GLUCOSE BLOOD LEVEL; GYNECOMASTIA; HEADACHE; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE FLUTTER; HUMAN; HYPERKINESIA; HYPERSALIVATION; IMPOTENCE; INSOMNIA; INTESTINE OBSTRUCTION; LIPID METABOLISM; MAJOR CLINICAL STUDY; MALE; MENSTRUAL IRREGULARITY; MULTICENTER STUDY; MUSCLE HYPERTONIA; MUSCLE RIGIDITY; MUSCLE SPASM; NAUSEA; NEUROLEPTIC MALIGNANT SYNDROME; OCULOGYRATION; ORTHOSTATIC HYPOTENSION; PARKINSONISM; PHASE 3 CLINICAL TRIAL; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; PSYCHOSIS; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; SCHIZOPHRENIA; SEDATION; SEXUAL DYSFUNCTION; SIDE EFFECT; SIMPSON ANGUS RATING SCALE; SINUS TACHYCARDIA; SOMNOLENCE; SUDDEN DEATH; SUICIDAL IDEATION; SUICIDE ATTEMPT; SYNCOPE; TABLET FORMULATION; TACHYCARDIA; TARDIVE DYSKINESIA; TORSADE DES POINTES; TREATMENT RESPONSE; TREMOR; TRIACYLGLYCEROL BLOOD LEVEL; VOMITING; WEIGHT GAIN;

EID: 45249095185     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.v69n0515     Document Type: Article

References (30)

1. Lehman AF, Buchanan RW, Dickerson FB, et al. Evidence-based treatment for schizophrenia. Psychiatr Clin North Am 2003;26:939-954
2. Lindenmayer JP, Khan A. Pharmacological treatment strategies for schizophrenia. Expert Rev Neurother 2004;4:705-723
3. Miller AL, Craig CS. Combination antipsychotics: pros, cons, and questions. Schizophr Bull 2002;28:105-109
4. Drake RE, McHugo GJ, Bebout RR, et al. A randomized clinical trial of supported employment for inner-city patients with severe mental disorders. Arch Gen Psychiatry 1999;56:627-633
5. Casey DE. Neuroleptic-induced acute extrapyramidal syndromes and tardive dyskinesia. Psychiatr Clin North Am 1993;16:589-610
6. Newcomer JW, Haupt DW. The metabolic effects of antipsychotic medications. Can J Psychiatry 2006;51:480-491
7. Oehl M, Hummer M, Fleischhacker WW. Compliance with antipsychotic treatment. Acta Psychiatr Scand Suppl 2000;407:83-86
8. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;353:1209-1223
9. Jones PB, Barnes TR, Davies L, et al. Randomized controlled trial of the effect on quality of life of second- vs first-generation antipsychotic drugs in schizophrenia: Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1). Arch Gen Psychiatry 2006;63:1079-1087
10. Schotte A, Janssen PF, Gommeren W, et al. Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding. Psychopharmacology (Berl) 1996;124:57-73
11. Schotte A, Janssen PF, Megens AA, et al. Occupancy of central neurotransmitter receptors by risperidone, clozapine and haloperidol, measured ex vivo by quantitative autoradiography. Brain Res 1993;631:191-202
12. 2 atypical antipsychotics. Am J Psychiatry 2005;162:1984-1985
13. Karlsson P, Dencker E, Nyberg S, et al. Pharmacokinetics and dopamine D2 and serotonin 5-HT2A receptor occupancy of paliperidone in healthy subjects [abstract]. Eur Neuropsychopharmacol 2005;15(suppl 3):S386
14. C paliperidone 1 mg in healthy subjects [abstract]. Clin Pharmacol Ther 2006;79(2):P80
15. Davidson M, Emsley R, Kramer M, et al. Efficacy, safety and early response of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Schizophr Res 2007;93:117-130
16. Kane JM, Canas F, Kramer M, et al. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr Res 2007;90:147-161
17. Marder SR, Kramer M, Ford L, et al. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week randomized, placebo-controlled study. Biol Psychiatry 2007;62(12):1363-1370
18. Morosini PL, Magliano L, Brambilla L, et al. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand 2000;101:323-329
19. Patrick D, Morosini PL, Rothman M, et al. Reliability, validity and sensitivity to change of the Personal and Social Performance scale in patients with acute schizophrenia [poster]. Presented at the 159th annual meeting of the American Psychiatric Association; May 20-25, 2006; Toronto, Ontario, Canada. NR416
20. Hunter RH, Joy CB, Kennedy E, et al. Risperidone versus typical antipsychotic medication for schizophrenia. Cochrane Database Syst Rev 2003;(2):CD000440
21. Emsley RA. Risperidone in the treatment of first-episode psychotic patients: a double-blind multicenter study. Risperidone Working Group. Schizophr Bull 1999;25(4):721-729
22. David SR, Taylor CC, Kinon BJ, et al. The effects of olanzapine, risperidone, and haloperidol on plasma prolactin levels in patients with schizophrenia. Clin Ther 2000;22:1085-1096
23. Gaedigk A, Bradford D, Marcucci KA, et al. Unique CYP2D6 activity distribution and genotype-phenotype discordance in black Americans. Clin Pharmacol Ther 2002;72:76-83
24. Mendoza R, Wan YJ, Poland RE, et al. CYP2D6 polymorphism in a Mexican American population. Clin Pharmacol Ther 2001;70:552-560
25. Rogers JF, Nafziger AN, Berino JS. Pharmacogenetics affects dosing, efficacy, and toxicity of cytochrome P450-metabolized drugs. Am J Med 2002;113:746-750
26. Berecz R, Dorado P, De La Rubia A, et al. The role of cytochrome P450 enzymes in the metabolism of risperidone and its clinical relevance for drug interactions. Curr Drug Targets 2004;5:573-579
27. Kapur S, Arenovich T, Agid O, et al. Evidence for onset of antipsychotic effects within the first 24 hours of treatment. Am J Psychiatry 2005;162:939-946
28. Emsley R, Rabinowitz J, Medori R. Time course for antipsychotic treatment response in first-episode schizophrenia. Am J Psychiatry 2006;163:743-745
29. Kramer M, Simpson G, Maciulis V, et al. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 2007;27(1):6-14
30. Vermeir M, Naessens I, Remmerie B, et al. Absorption, metabolism, and excretion of paliperidone, a new monoaminergic antagonist, in humans. Drug Metab Dispos 2008;36(4):769-779