Paliperidone: The evidence of its therapeutic value in schizophrenia

Core Evidence

Volumn 2, Issue 4, 2008, Pages 261-271

  Kantrowitz, Joshua ^a   Citrome, Leslie ^a,b  

^a NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

^b NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical impact; Cost effectiveness; Evidence; Paliperidone; Schizophrenia

Indexed keywords

4 AMINOBUTYRIC ACID; AMISULPRIDE; ARIPIPRAZOLE; CARBAMAZEPINE; CATECHOL METHYLTRANSFERASE; CHLORPROMAZINE; CLOZAPINE; DOPAMINE; DOPAMINE 2 RECEPTOR; DYSBINDIN; FLUOXETINE; HALOPERIDOL; LAMOTRIGINE; MIRTAZAPINE; NEUROLEPTIC AGENT; OLANZAPINE; PALIPERIDONE; PAROXETINE; PERPHENAZINE; PLACEBO; QUETIAPINE; RGS4 PROTEIN; RISPERIDONE; SEROTONIN 2A RECEPTOR; SERTRALINE; TOPIRAMATE; UNINDEXED DRUG; VALPROIC ACID; VENLAFAXINE; ZIPRASIDONE;

ACUTE PSYCHOSIS; AKATHISIA; AMENORRHEA; ANORGASMIA; ANTICHOLINERGIC SYNDROME; BLOOD DYSCRASIA; CLINICAL TRIAL; COGNITIVE DEFECT; COST EFFECTIVENESS ANALYSIS; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG BRAIN LEVEL; DRUG COMPETITION; DRUG COST; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG EXCRETION; DRUG METABOLISM; DRUG POTENCY; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSTONIA; EVIDENCE BASED MEDICINE; EXTRAPYRAMIDAL SYMPTOM; GALACTORRHEA; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM; GYNECOMASTIA; HEALTH CARE UTILIZATION; HUMAN; HYPERPROLACTINEMIA; INSOMNIA; LOW DRUG DOSE; MEAN RESIDENCE TIME; METABOLIC DISORDER; MORNING DOSAGE; NEGATIVE SYNDROME; NEUROLEPTIC MALIGNANT SYNDROME; NONHUMAN; ORTHOSTATIC HYPOTENSION; PARKINSONISM; PATHOPHYSIOLOGY; PATIENT COMPLIANCE; POSITIVE SYNDROME; PREVALENCE; PROTEIN EXPRESSION; PSYCHOSOCIAL CARE; PSYCHOTHERAPY; QT PROLONGATION; QUALITY OF LIFE; RECOMMENDED DRUG DOSE; RELAPSE; REVIEW; RISK FACTOR; SCHIZOPHRENIA; SEDATION; SEXUAL DYSFUNCTION; SIDE EFFECT; SOMNOLENCE; TACHYCARDIA; TARDIVE DYSKINESIA; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; URINARY EXCRETION; URINE INCONTINENCE; WEIGHT GAIN;

EID: 54649084960     PISSN: 15551741     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (90)

1. Aichhorn W, Stuppaeck C, Whitworth A. Risperidone and breast-feeding. J Psychopharmacol. 2005a;19:211-213.
2. Aichhorn W, Weiss U, Marksteiner J, et al. Influence of age and gender on risperidone plasma concentrations. J Psychopharmacol. 2005b;19:395-401.
3. Akbarian S, Kim J, Potkin S, Hetrick W, Burney WJ, Jones E. Maldistribution of interstitial neurons in prefrontal white matter of the brains of schizophrenic patients. Arch Gen Psychiatry. 1996;53:425-436.
4. Amchin J, Zarycranski W, Taylor K, Albano D, Klockowski P. Effect of venlafaxine on the pharmacokinetics of risperidone. J Clin Pharmacol. 1999;39:297-309,
5. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC. American Psychiatric Association; 2000,
6. Anon. Invega (paliperidone) Extended-Pelease Tablets. Available at: hftp://www.invega.com/invega/shared/pl~/invega,pdf#zoom=100 (accessed September 5, 2007a).
7. Anon. Ontario Drug Benefit Formulary/Comparative Drug Index: Electronic Version. Available at: http://www.health.gov.on.ca/english/ providers/program/drugs/odbf_eformulary. html (accessed September 5 2007b).
8. Anon. Risperoal (risperidone). Available at: http://www.risperdal.com/risperdal/shared/pl~/risperdal.pdf (accessed September 5, 2007c).
9. Aravagiri M, Marder S, Nuechterlein K, Gitlin M. Intra- and interindividual variations in steady-state plasma concentrations of risperidone and 9-hydroxyrisperidone in schizophrenic patients treated chronically with various doses of risperidone. Ther Drug Monit. 2003;25:657-664.
10. Benes F, Kwok E, Vincent S, Todtenkopf M. A reduction of nonpyramidal cells in sector CA2 of schizophrenics and manic depressives. Biol Psychiatry. 1998;44:88-97.
11. Boks M, Rietkerk T, van de Beek M, Sommer I, de Koning T, Kahn R. Reviewing the role of the genes G72 and DAAO in glutamate neurotransmission in schizophrenia. Eur Neuropsychopharmacol. 2007;17:567-572.
12. Bondolfi G, Eap, C, Bertschy G, Zullino D, Vermeulen A, Baumann P. The effect of fluoxetine on the pharmacokinetics and safety of risperidone in psychotic patients. Pharmacopsychiatry. 2002;35:50-56.
13. Castle E, Wessely S, Der G, Murray R. The incidence of operationally defined schizophrenia in Camberwell 1965-84. Br J Psychiatry. 1991-159:790-794.
14. Chouinard G, Jones B, Remington G, et al. A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients. J Clin Psychopharmacol. 1993;13:25-40.
15. Citrome L. The effectiveness criterion: balancing efficacy against the risk of weight gain. J Clin Psychiatry. 2007;68:12-17.
16. Conley R, Gupta S, Sathyan G. Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form. Curr Med Res Opin. 2006;22:1879-1892.
17. Correll C, Leucht S, Kane JM. Lower risk for tardive dyskinesia associated with second-generation antipsychotics: a systematic review of 1-year studies. Am J Psychiatry. 2004:161:414-425.
18. Csernansky J, Schuchart E. Relapse and rehospitalisation rates in patients with schizophrenia: effects of second generation antipsychotics, CNS Drugs. 2002;16:473-484.
19. Davidson M, Emsley R, Kramer M, et al, Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007;93:117-130.
20. Davis J, Chen N, Glick I. A meta-analysis of the efficacy of second-generation antipsychotics. Arch Gen Psychiatry. 2003;60:553-564.
21. Davis JM, Chen N. Dose response and dose equivalence of antipsychotics. J Clin Psychopharmacol. 2004;24:192-208.
22. Davis KL, Stewart DG, Friedman JI, et al. White matter changes in schizophrenia: evidence for myelin-related dysfunction. Arch Gen Psychiatry. 2003;60:443-456.
23. Di Forti M, Lappin JM, Murray RM. Risk factors for schizophrenia-all roads lead to dopamine. Eur Neuropsychopharmacol. 2007;1 7:S101-S107.
24. Dursun S, Patel J, Burke J. Reveley M. Effects of typical antipsychotic drugs and risperidone on the quality of sleep in patients with schizophrenia: a pilot study. J Psychiatry Neurosci. 1999;24:333-337.
25. Eberhard-Gran M, Eskild A, Opjordsmoen S. Use of psychotropic medications in treating mood disorders during lactation: practical recommendations. CNS Drugs. 2006;20:187-198.
26. Folsom DP, Hawthorne W, Lindamer L, et al. Prevalence and risk factors for homelessness and utilization of mental health services among 10,340 patients with serious mental illness in a large public mental health system. Am J Psychiatry. 2005;162:370-376.
27. Göder R, Boigs M, Braun S, et al. Impairment of visuospatial memory is associated with decreased slow wave sleep in schizophrenia. J Psychiatr Res. 2004;38:591-599.
28. Goldner EM, Hsu L, Waraich P, Somers JM. Prevalence and incidence studies of schizophrenic disorders: a systematic review of the literature. Can J Psychiatry. 2002;47:833-843.
29. Green Al, Drake RE, Brunette MF, Noordsy DL. Schizophrenia and co-occurring substance use disorder. Am J Psychiatry. 2007;164:402-408.
30. Green M, Kern R, Braff D, Mintz J. Neurocognitive deficits and functional outcome in schizophrenia: are we measuring the "right stuff"? Schizophr Bull. 2000;26:119-136.
31. Häfner H, an der Heiden H. The course of schizophrenia in the light of modern follow-up studies: the ABC and WHO studies. Eur Arch Psychiatry Clin Neurosci. 1999;249:14-26.
32. Harrison F, Weinberger D. Schizophrenia genes, gene expression, and neuropathology: on the matter of their convergence. Mol Psychiatry. 2005;10:40-68,
33. Heresco-Levy U, Javitt DC, Ebstein R, et al. D-Serine efficacy as add-on pharmacotherapy to risperidone and olanzapine for treatment-refractory schizophrenia. Biol Psychiatry. 2005;57:577-585.
34. Hoffman RE, McGlashan TH. Synaptic elimination, neurodevelopment, and the mechanism of hallucinated "voices" in schizophrenia. Am J Psychiatry. 1997;154:1683-1689.
35. Hofstetter JR, Lysalker PH, Mayeda AR. Quality of sleep in patients with schizophrenia is associated with quality of life and coping. BMC Psychiatry. 2005;5:13,
36. Howes OD, Wheeler MJ, Meaney A-M, et al. Bone mineral density and its relationship to prolactin levels in patients taking antipsychatic treatment. J Clin Psychopharmacol. 2005;25:259-261,
37. Hunt IM, Kapur N, Windfuhr K, et al; National confidential inquiry into suicide and homicide by people with mental illness. Suicide in schizophrenia: findings from a national clinical survey. J Psychiatr Pract. 2006;12:139-147.
38. Javitt DC. Glutamate as a therapeutic target in psychiatric disorders. Mol Psychiatry. 2004:9:984-997.
39. Javitt DC, Coyle JT. Decoding schizophrenia. Sci Am. 2004;290:48-55.
40. Jeste D, Lohr J, Hippocampal pathologic findings in schizophrenia: a morphometric study, Arch Gen Psychiatry. 1989;46:1019-1024.
41. Jones P, Barnes T, 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.
42. 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.
43. Kantrowitz JT, Srihari VH, Tek C. Three cases of risperidone-induced enuresis. Schizophr Res. 2006;84:174-175.
44. Keefe R, Perkins D, Gu H, Zipursky R, Christensen B, Lieberman J. A longitudinal study of neurocognitive function in individuals at-risk for psychosis. Schizophr Res. 2006;88:26-35.
45. Knegtering R, Baselmans P, Castelein S, Bosker F, Bruggeman R, van den Bosch R. Predominant role of the 9-hydroxy metabolite of risperidone in elevating blood prolactin levels, Am J Psychiatry. 2005;162:1010-1012.
46. 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-conlrolled study. J Clin Psychopharmacol. 2007;27:6-14.
47. Kubicki M, Shenton M, Salisbury D, et al. Voxel-based morphometric analysis of gray matter in first episode schizophrenia. Neurcrimage. 2002;17:1711-1719.
48. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engi J Med. 2005;353:1209-1223.
49. Loonen A, Doorschot C, Oostelbos M, Sitsen J. Lack of drug interactions between mirtazapine and risperidone in psychiatric patients: a pilot study. Eur Neuropsychopharmacol. 1999;10:51-57.
50. Luthringer R, Staner L, Noel N, et al. A double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone extended-release tablets on sleep architecture in patients with schizophrenia. Int Clin Psychopharmacol. 2007;22:299-308,
51. Marder S, Glynn S, Wirshing W, et al. Maintenance treatment of schizophrenia with risperidone or haloperidol: 2-year outcomes. Am J Psychiatry. 2003;160:1405-1412.
52. Marder S, 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;62:1363-1370.
53. McEvoy JP, Lieberman JA, Stroup TS, et al. Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment. Am J Psychiatry. 2006;163:600-610.
54. Melkersson KI. Prolactin elevation of the antipsychotic risperidone is predominantly related to its 9-hydroxy metabolite. Hum Psychopharmacol. 2006;21:529-532.
55. Migliardi G, D'Arrigo C, Santoro V, et al. Effect of topiramate on plasma concentrations of clozapine, olanzapine, risperidone, and quetiapine in patients with psychotic disorders. Clin Neuropharmacol. 2007;30:107-113.
56. Mitchell AJ, Malone D. Physical health and schizophrenia. Curr Opin Psychiatry. 2006;19:432-437.
57. Molitch ME. Medication-induced hyperprolactinemia. Mayo Clin Proc. 2005;80:1050-1057.
58. Moore TH, Zammit S, Lingford-Hughes A, et al. Cannabis use and risk of psychotic or affective mental health outcomes: a systematic review. Lancet. 2007;370:319-32B.
59. Morosini P, Magliano L, Brambilla L, Ugollni S, Pioli R. 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.
60. Muller N, Schwarz M. Schizophrenia as an inflammation-mediated dysbalance of glutamatergic neurotransmission. Neurotox Res. 2006;10:131-148.
61. Nesvåg R, Hendset M, Refsum H, Tanum L. Serum concentrations of risperidone and 9-OH risperidone following intramuscular injection of long-acting risperidone compared with oral risperidone medication. Acta Psychiatr Scand. 2006;114:21-26.
62. Norton N, Williams HJ, Owen MJ. An update on the genetics of schizophrenia. Curr Opin Psychiatry. 2006;19:158-164.
63. Nussbaum A, Stroup S. Paliperidone for schizophrenia. (Protocol). Cochrane Database Syst Rev. 2007;DOI 10.1002/14651858.CDO06369.
64. Parrott A, Hindmarch 1. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71:173-179.
65. Patil ST, Zhang L, Martenyi F, et al. Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: a randomized Phase 2 clinical trial. Nat Med. 2007;13:1102-1107.
66. Polsky D, Doshi J, Bauer M, Glick H. Clinical trial based cost-effectiveness analyses of antipsychotic use. Am J Psychiatry. 2006;163: 2047-2056.
67. Potkin S, Gharabawi G, Greenspan A, et al. A double-blind comparison of risperidone, quetiapine and placebo in patients with schizophrenia experiencing an acute exacerbation requiring hospitalization. Schizophr Res. 2006;85:254-265.
68. Ravindran A, Silverstone F, Lacroix D, van Schaick E, Vermeulen A, Alexander J. Risperidone does not affect steady-state pharmacolkinetics of divalproex sodium in patients with bipolar disorder. Clin Pharmacokinet. 2004;43:733-740.
69. Reichenberg A, Weiser M, Rapp M, et al. Self-reported mental health difficulties and subsequent risk for schizophrenia in females: a 5-year follow-up cohort study. Schizophr Res. 2005;82:233-239.
70. Ritsner M, Kurs R, Ponizovsky A, Hadjez J. Perceived quality of life in schizophrenia: relationships to sleep quality. Qual Life Res. 2004;13:783-791.
71. Rosenheck RA. Evaluating the cost-effectiveness of reduced tardive dyskinesia with second-generation antipsychotics. Br J Psychiatry. 2007;191:238-245.
72. Rosenheck RA, Leslie D, Sindelar J, et al. Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia. Am J Psychiatry. 2006;163:2080-2089.
73. Saito M, Yasui-Furukori N, Nalkagami T Furukori H, Kaneko S. Dose-dependent interaction of paroxetine with risperidone in schizophrenic patients. J Clin Psychopharmacol. 2005;25:527-532.
74. Seeman P. An update of fast-off dopamine D2 atypical antipsychotics. Am J Psychiatry. 2005;162:1984-1985.
75. Shayegan D, Stahl S. Atypical antipsychotics: matching receptor profile to individual patient's clinical profile. CNS Spectr. 2004;9:6-14.
76. Siegel S, Irani F, Brensinger C, et al. Prognostic variables at intake and long-term level of function in schizophrenia. Am J Psychiatry. 2006;163:433-441.
77. Spina E, Avenoso A, Facciolàa G, et al. Relationship between plasma risperidone and 9-hydroxyrisperidone concentrations and clinical response in patients with schizophrenia. Psychopharmacology (Berl). 2001;153:238-243.
78. Spina E, Avenoso A, Facciolàa G, et al. Plasma concentrations of risperidone and 9-hydroxyrisperidone: effect of comedication with carbamazepine or valproate. Ther Drug Monit. 2000;22:481-485.
79. Spina E, D'Arrigo C, Migliardi G, et al. Plasma rispendone concentrations during combined treatment with sertraline. Ther Drug Monit.. 2004;26:386-390.
80. Spina E, D'Arrigo C, Migliardi G, et al. Effect of adjunctive lamotrigine treatment on the plasma concentrations of clozapine, risperidone and olanzapine in patients with schizophrenia or bipolar disorder. Ther Drug Monit. 2006;28:599-602.
81. Stahl S, Buckley P. Negative symptoms of schizophrenia: a problem that will not go away. Acta Psychiatr Scand. 2007;115:4-11.
82. Swartz MS, Perkins DO, Stroup TS, et al. Effects of antipsychotic medications on psychosocial functioning in patients with chronic schizophrenia: findings from the NIMH CATIE Study. Am J Psychiatry. 2007;164:428-436.
83. Vacher CM, Gassmann M, Desrayaud S, et al, Hyperdopaminergia and altered locomotor activity in GABAB1 -deficient mice. J Neurochem 2006;97:979-991.
84. van Beijsterveldt L, Geerts R, Leysen J, et al. Regional brain distribution of risperidone and its active metabolite 9-hydroxy-risperidone in the rat. Psychopharmacology (Berl). 1994;114:53-62.
85. Vera PL, Miranda-Sousa A, Nadelhaft 1. Effects of two atypical neuroleptics, olanzapine and risperidone, on the function of the urinary bladder and the external urethral sphincter in anesthetized rats. BMC Pharmacol. 2001;1:4.
86. Weiden PJ. EPS profiles: the atypical antipsychotics are not all the same. J Psychiatr Pract. 2007;13:13-24.
87. Woo T, Whitehead R, Melchitzky D, Lewis D. A subclass of prefrontal gamma-aminobutyric acid axon terminals are selectively altered in schizophrenia. Proc Natl Acad Sci U S A. 1998;95:5341-5346.
88. Yang C, Winkelman JW. Clinical significance of sleep EEG abnormalities in chronic schizophrenia. Schizophr Res.. 2006;82:251-260.
89. Yoshimura R, Shinkai K, Ueda N, Nakamura J. Valproic acid improves psychotic agitation without influencing plasma risperidone levels in schizophrenic patients. Pharmacopsychiatry. 2007;40:9-13.
90. Zhu H-J, Wang J-S, Markowitz JS, Donovan JL, Gibson BB, DeVane CL. Risperidone and paliperidone inhibit P-glycoprote in activity in vitro. Neuropsychopharmacol. 2007;32:757-764.