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Guidance for switching from off-label antipsychotics to pimavanserin for Parkinson’s disease psychosis: an expert consensus

Published online by Cambridge University Press:  27 December 2018

Kevin J. Black Open the ORCID record for Kevin J. Black [Opens in a new window] ,
Henry Nasrallah Open the ORCID record for Henry Nasrallah [Opens in a new window] ,
Stuart Isaacson ,
Mark Stacy ,
Rajesh Pahwa ,
Charles H. Adler ,
Gustavo Alva ,
Jeffrey W. Cooney ,
Daniel Kremens  and
Matthew A. Menza
...Show all authors
Kevin J. Black*
Affiliation:
Departments of Psychiatry, Neurology, Radiology, and Neuroscience, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA
Henry Nasrallah
Affiliation:
Department of Psychiatry and Behavioral Neuroscience, Saint Louis University School of Medicine, St. Louis, Missouri, USA
Stuart Isaacson
Affiliation:
Parkinson’s Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, USA
Mark Stacy
Affiliation:
Brody School of Medicine, East Carolina University, Greenville, North Carolina, USA
Rajesh Pahwa
Affiliation:
Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA
Charles H. Adler
Affiliation:
Department of Neurology, Mayo Clinic College of Medicine, Scottsdale, Arizona, USA
Gustavo Alva
Affiliation:
Department of Psychiatry and Neuroscience, University of California, Riverside, Riverside, California, USA ATP Clinical Research, Costa Mesa, California, USA
Jeffrey W. Cooney
Affiliation:
Department of Neurology, Duke University School of Medicine, Durham, North Carolina, USA
Daniel Kremens
Affiliation:
Comprehensive Parkinson’s Disease and Movement Disorders Center at the Vickie and Jack Farber Center for Neurosciences at the Sidney Kimmel Medical School at Jefferson University, Philadelphia, Philadelphia, USA
Matthew A. Menza
Affiliation:
Department of Psychiatry, Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA
Jonathan M. Meyer
Affiliation:
California Department of State Hospitals, Sacramento, California, USA Department of Psychiatry, University of California, San Diego, La Jolla, California, USA
Ashwin A. Patkar
Affiliation:
Department of Psychiatry & Community and Family Medicine, Duke University Medical Center, Durham, North Carolina, USA
Tanya Simuni
Affiliation:
Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Debbi A. Morrissette
Affiliation:
Neuroscience Education Institute, Carlsbad, California, USA
Stephen M. Stahl
Affiliation:
Department of Psychiatry, University of California, San Diego, La Jolla, California, USA Neuroscience Education Institute, Carlsbad, California, USA
*
*Address for correspondence: Kevin J. Black, MD, Campus Box 8134, 660 S. Euclid Ave., St. Louis, MO 63110-1093, USA. (Email: [email protected])
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Abstract

Patients with Parkinson’s disease psychosis (PDP) are often treated with an atypical antipsychotic, especially quetiapine or clozapine, but side effects, lack of sufficient efficacy, or both may motivate a switch to pimavanserin, the first medication approved for management of PDP. How best to implement a switch to pimavanserin has not been clear, as there are no controlled trials or case series in the literature to provide guidance. An abrupt switch may interrupt partially effective treatment or potentially trigger rebound effects from antipsychotic withdrawal, whereas cross-taper involves potential drug interactions. A panel of experts drew from published data, their experience treating PDP, lessons from switching antipsychotic drugs in other populations, and the pharmacology of the relevant drugs, to establish consensus recommendations. The panel concluded that patients with PDP can be safely and effectively switched from atypical antipsychotics used off label in PDP to the recently approved pimavanserin by considering each agent’s pharmacokinetics and pharmacodynamics, receptor interactions, and the clinical reason for switching (efficacy or adverse events). Final recommendations are that such a switch should aim to maintain adequate 5-HT2A antagonism during the switch, thus providing a stable transition so that efficacy is maintained. Specifically, the consensus recommendation is to add pimavanserin at the full recommended daily dose (34 mg) for 2–6 weeks in most patients before beginning to taper and discontinue quetiapine or clozapine over several days to weeks. Further details are provided for this recommendation, as well as for special clinical circumstances where switching may need to proceed more rapidly.

Keywords

Parkinson Disease:complicationspsychotic disorders:therapyantipsychotic agentspimavanserin
Type
Guidelines
Information
CNS Spectrums , Volume 23 , Special Issue 6: Theme: Neuropsychiatry , December 2018 , pp. 402 - 413
Copyright
© Cambridge University Press 2018 

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Footnotes

Previous errors have been corrected. See doi: 10.1017/S1092852919000932.

References

1. Weintraub, D, Stern, MB. Psychiatric complications in Parkinson disease. Am J Geriatr Psychiatry. 2005; 13(10): 844–851.Google Scholar
2. Ravina, B, Marder, K, Fernandez, HH, et al. Diagnostic criteria for psychosis in Parkinson’s disease: report of an NINDS, NIMH work group. Mov Disord. 2007; 22(8): 1061–1068.Google Scholar
3. Friedman, JH. Parkinson disease psychosis: update. Behav Neurol. 2013; 27(4): 469–477.Google Scholar
4. Goetz, CG, Diederich, NJ, Fénelon, G. Psychosis in Parkinson’s disease. In: Chaudhuri KR, Tolosa E, Schapira AHV, Poewe W, eds. Non-Motor Symptoms of Parkinson’s Disease. 2nd ed. Oxford, UK: Oxford University Press; 2014: 184–208.Google Scholar
5. Weintraub, D, Chen, P, Ignacio, RV, Mamikonyan, E, Kales, HC. Patterns and trends in antipsychotic prescribing for Parkinson disease psychosis. Arch Neurol. 2011; 68(7): 899–904.Google Scholar
6. Weintraub, D, Chiang, C, Kim, HM, et al. Association of antipsychotic use with mortality risk in patients with Parkinson disease. JAMA Neurol. 2016; 73(5): 535–541.Google Scholar
7. Stahl, SM. Parkinson’s disease psychosis as a serotonin-dopamine imbalance syndrome. CNS Spectr. 2016; 21(5): 355–359.Google Scholar
8. Divac, N, Prostran, M, Jakovcevski, I, Cerovac, N. Second-generation antipsychotics and extrapyramidal adverse effects. Biomed Res Int. 2014; 2014: 656370.Google Scholar
9. Nasrallah, HA, Tandon, R. Classic Antipsychotic Medications. Arlington, VA: The American Psychiatric Association; 2017.Google Scholar
10. Black, KJ. Treatment of Parkinson’s disease psychosis. Med Int Rev. 2017; 27(109): 266–271.Google Scholar
11. Hawkins, T, Berman, BD. Pimavanserin: a novel therapeutic option for Parkinson disease psychosis. Neurol Clin Pract. 2017; 7(2): 157–162.Google Scholar
12. Vanover, KE, Harvey, SC, Son, T, et al. Pharmacological characterization of AC-90179 [2-(4-methoxyphenyl)-N-(4-methyl-benzyl)-N-(1-methyl-piperidin-4-yl)-acetamide hydrochloride]: a selective serotonin 2A receptor inverse agonist. J Pharmacol Exp Ther. 2004; 310(3): 943–951.Google Scholar
13. ACADIA Pharmaceuticals Inc. NUPLAZID® [package insert]. San Diego, CA; 2016.Google Scholar
14. Weiner, DM, Burstein, ES, Nash, N, et al. 5-Hydroxytryptamine2A receptor inverse agonists as antipsychotics. J Pharmacol Exp Ther. 2001; 299(1): 268–276.Google Scholar
15. Meltzer, HY, Mills, R, Revell, S, et al. Pimavanserin, a serotonin(2A) receptor inverse agonist, for the treatment of Parkinson’s disease psychosis. Neuropsychopharmacology. 2010; 35(4): 881–892.Google Scholar
16. Cummings, J, Isaacson, S, Mills, R, et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014; 383(9916): 533–540.Google Scholar
17. Mills, R, Friedman, J, Ondo, W, et al. Efficacy and tolerability of NUPLAZID® (pimavanserin) in PD psychosis: analysis of an integrated phase 3 placebo-controlled dataset. Paper presented at: XXI World Congress on Parkinson’s Disease and Related Disorders; December 6–9, 2015; Milan, Italy.Google Scholar
18. Friedman, JH. A retrospective study of pimavanserin use in a movement disorders clinic. Clin Neuropharmacol. 2017; 40(4): 157–159.Google Scholar
19. Takeuchi, H, Kantor, N, Uchida, H, Suzuki, T, Remington, G. Immediate vs gradual discontinuation in antipsychotic switching: a systematic review and meta-analysis. Schizophr Bull. 2017; 43(4): 862–871.Google Scholar
20. Cerovecki, A, Musil, R, Klimke, A, et al. Withdrawal symptoms and rebound syndromes associated with switching and discontinuing atypical antipsychotics: theoretical background and practical recommendations. CNS Drugs. 2013; 27(7): 545–572.Google Scholar
21. Li, P, Snyder, GL, Vanover, KE. Dopamine targeting drugs for the treatment of schizophrenia: past, present and future. Curr Top Med Chem. 2016; 16(29): 3385–3403.Google Scholar
22. Seppi, K, Weintraub, D, Coelho, M, et al. The Movement Disorder Society evidence-based medicine review update: treatments for the non-motor symptoms of Parkinson’s disease. Mov Disord. 2011; 26(Suppl 3): S42–80.Google Scholar
23. American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015; 63(11): 2227–2246.Google Scholar
24. Miyasaki, JM, Shannon, K, Voon, V, et al. Practice parameter: evaluation and treatment of depression, psychosis, and dementia in Parkinson disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006; 66(7): 996–1002.Google Scholar
25. Meco, G, Alessandria, A, Bonifati, V, Giustini, P. Risperidone for hallucinations in levodopa-treated Parkinson’s disease patients. Lancet. 1994; 343(8909): 1370–1371.Google Scholar
26. Workman, RH Jr, Orengo, CA, Bakey, AA, Molinari, VA, Kunik, ME. The use of risperidone for psychosis and agitation in demented patients with Parkinson’s disease. J Neuropsychiatry Clin Neurosci. 1997; 9(4): 594–597.Google Scholar
27. Nichols, MJ, Hartlein, JM, Eicken, MG, Racette, BA, Black, KJ. A fixed-dose randomized controlled trial of olanzapine for psychosis in Parkinson disease. F1000Res. 2013; 2: 150.Google Scholar
28. Ondo, WG, Levy, JK, Vuong, KD, Hunter, C, Jankovic, J. Olanzapine treatment for dopaminergic-induced hallucinations. Mov Disord. 2002; 17(5): 1031–1035.Google Scholar
29. Fernandez, HH, Trieschmann, ME, Friedman, JH. Aripiprazole for drug-induced psychosis in Parkinson disease: preliminary experience. Clin Neuropharmacol. 2004; 27(1): 4–5.Google Scholar
30. Gray, NS. Ziprasidone-related neuroleptic malignant syndrome in a patient with Parkinson’s disease: a diagnostic challenge. Hum Psychopharmacol. 2004; 19(3): 205–207.Google Scholar
31. Schindehütte, J, Trenkwalder, C. Treatment of drug-induced psychosis in Parkinson’s disease with ziprasidone can induce severe dose-dependent off-periods and pathological laughing. Clin Neurol Neurosurg. 2007; 109(2): 188–191.Google Scholar
32. The French Clozapine Parkinson Study Group. Clozapine in drug-induced psychosis in Parkinson’s disease. Lancet. 1999; 353(9169): 2041–2042.Google Scholar
33. The Parkinson Study Group. Low-dose clozapine for the treatment of drug-induced psychosis in Parkinson’s disease. N Engl J Med. 1999; 340(10): 757–763.Google Scholar
34. Pollak, P, Tison, F, Rascol, O, et al. Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up. J Neurol Neurosurg Psychiatry. 2004; 75(5): 689–695.Google Scholar
35. Morgante, L, Epifanio, A, Spina, E, et al. Quetiapine and clozapine in parkinsonian patients with dopaminergic psychosis. Clin Neuropharmacol. 2004; 27(4): 153–156.Google Scholar
36. Alvir, JM, Lieberman, JA, Safferman, AZ, Schwimmer, JL, Schaaf, JA. Clozapine-induced agranulocytosis: incidence and risk factors in the United States. N Engl J Med. 1993; 329(3): 162–167.Google Scholar
37. Merims, D, Balas, M, Peretz, C, Shabtai, H, Giladi, N. Rater-blinded, prospective comparison: quetiapine versus clozapine for Parkinson’s disease psychosis. Clin Neuropharmacol. 2006; 29(6): 331–337.Google Scholar
38. Klein, C, Prokhorov, T, Miniovich, A, Dobronevsky, E, Rabey, JM. Long-term follow-up (24 months) of quetiapine treatment in drug-induced Parkinson disease psychosis. Clin Neuropharmacol. 2006; 29(4): 215–219.Google Scholar
39. Fernandez, HH, Okun, MS, Rodriguez, RL, et al. Quetiapine improves visual hallucinations in Parkinson disease but not through normalization of sleep architecture: results from a double-blind clinical-polysomnography study. Int J Neurosci. 2009; 119(12): 2196–2205.Google Scholar
40. Kurlan, R, Cummings, J, Raman, R, et al. Quetiapine for agitation or psychosis in patients with dementia and parkinsonism. Neurology. 2007; 68(17): 1356–1363.Google Scholar
41. Ondo, WG, Tintner, R, Voung, KD, Lai, D, Ringholz, G. Double-blind, placebo-controlled, unforced titration parallel trial of quetiapine for dopaminergic-induced hallucinations in Parkinson’s disease. Mov Disord. 2005; 20(8): 958–963.Google Scholar
42. Rabey, JM, Prokhorov, T, Miniovitz, A, Dobronevsky, E, Klein, C. Effect of quetiapine in psychotic Parkinson’s disease patients: a double-blind labeled study of 3 months’ duration. Mov Disord. 2007; 22(3): 313–318.Google Scholar
43. Shotbolt, P, Samuel, M, Fox, C, David, AS. A randomized controlled trial of quetiapine for psychosis in Parkinson’s disease. Neuropsychiatr Dis Treat. 2009; 5: 327–332.Google Scholar
44. Friedman, JH. Quetiapine for Parkinson’s disease psychosis: evidence-based medicine versus expert belief: a case study. Mov Disord. 2018; 33(7): 1186–1187.Google Scholar
45. Wilby, KJ, Johnson, EG, Johnson, HE, Ensom, MHH. Evidence-based review of pharmacotherapy used for Parkinson’s disease psychosis. Ann Pharmacother. 2017; 51(8): 682–695.Google Scholar
46. Hacksell, U, Burstein, ES, McFarland, K, Mills, RG, Williams, H. On the discovery and development of pimavanserin: a novel drug candidate for Parkinson’s psychosis. Neurochem Res. 2014; 39(10): 2008–2017.Google Scholar
47. Voss, T, Bahr, D, Cummings, J, Mills, R, Ravina, B, Williams, H. Performance of a shortened Scale for Assessment of Positive Symptoms for Parkinson’s disease psychosis. Parkinsonism Relat Disord. 2013; 19(3): 295–299.Google Scholar
48. Citrome, L, Norton, JC, Chi-Burris, K, Demos, G. Pimavanserin for the treatment of Parkinson’s disease psychosis: number needed to treat, number needed to harm, and likelihood to be helped or harmed. CNS Spectr. 2018; 23(3): 228–238.Google Scholar
49. Mathis, MV. NDA Approval/Supplement Approval. In: Center for Drug Evaluation and Research, ed. Silver Spring, MD: Food and Drug Administration; 2018. http://www.webcitation.org/query?url=https%3A%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda_docs%2Fappletter%2F2018%2F210793Orig1s000%2C207318Orig1s003ltr.pdf&date=2018-07-20 Google Scholar
50. Mills, R, Isaacson, S, Azulay, J-P, et al. Long-term effectiveness of NUPLAZID® (pimavanserin) in PD psychosis: data from 2 open-label studies. Paper presented at: XXI World Congress on Parkinson’s Disease and Related Disorders; December 6–9, 2015; Milan, Italy.Google Scholar
51. Correll, CU. From receptor pharmacology to improved outcomes: individualising the selection, dosing, and switching of antipsychotics. Eur Psychiatry. 2010; 25(Suppl 2): S12–21.Google Scholar