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Original Article

An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study)

, , , , &
Pages 191-199 | Received 03 Aug 2017, Accepted 31 Oct 2017, Published online: 21 Nov 2017

References

  • Alphs, L., Bossie, C.A., Sliwa, J.K., Ma, Y.W., & Turner, N. (2011). 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. Annals of General Psychiatry, 10(1), 12. doi:10.1186/1744-859X-10-12
  • Alphs, L., Mao, L., Lynn Starr, H., & Benson, C. (2016). A pragmatic analysis comparing once-monthly paliperidone palmitate versus daily oral antipsychotic treatment in patients with schizophrenia. Schizophrenia Research, 170, 259–264. doi:10.1016/j.schres.2015.12.012
  • Alphs, L., Schooler, N., & Lauriello, J. (2014). How study designs influence comparative effectiveness outcomes: The case of oral versus long-acting injectable antipsychotic treatments for schizophrenia. Schizophrenia Research, 156, 228–232. doi:10.1016/j.schres.2014.04.024
  • Alvarez-Jimenez, M., Parker, A. G., Hetrick, S. E., McGorry, P. D., & Gleeson, J. F. (2011). Preventing the second episode: A systematic review and meta-analysis of psychosocial and pharmacological trials in first-episode psychosis. Schizophrenia Bulletin, 37, 619–630. doi:10.1093/schbul/sbp129
  • Atkinson, M. J., Sinha, A., Hass, S. L., Colman, S. S., Kumar, R. N., Brod, M., & Rowland, C. R. (2004). Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health and Quality of Life Outcomes, 2:12. doi:10.1186/1477-7525-2-12
  • Bera, R., Offord, S., Zubek, D., Lau, G., Lin, J., Baker, R. A., & Karson, C. (2013). Impact on healthcare resource usage and costs among Medicaid-insured schizophrenia patients after initiation of treatment with long-acting injectable antipsychotics. Journal of Medical Economics, 16, 522–528. doi:10.3111/13696998.2013
  • Bera, R., Offord, S., Zubek, D., Lau, G., Lin, J., & Karson, C. (2014). Hospitalization resource utilization and costs among Medicaid insured patients with schizophrenia with different treatment durations of long-acting injectable antipsychotic therapy. Journal of Clinical Psychopharmacology, 34(1), 30–35. doi:10.1097/JCP.0b013e3182a6082a
  • Bergendal, A., Schioler, H., Wettermark, B., & Bjorksten, K. S. (2015). Concomitant use of two or more antipsychotic drugs is common in Sweden. Therapeutic Advances in Psychopharmacology, 5, 224–231. doi:10.1177/2045125315588647
  • Bressington, D., Stock, J., Hulbert, S., & MacInnes, D. (2015). A retrospective observational study of the effectiveness of paliperidone palmitate on acute inpatient hospitalization rates. International Clinical Psychopharmacology, 30, 230–236. doi:10.1097/YIC.0000000000000077
  • Brissos, S., Veguilla, M. R., Taylor, D., & Balanza-Martinez, V. (2014). The role of long-acting injectable antipsychotics in schizophrenia: A critical appraisal. Therapeutic Advances in Psychopharmacology, 4, 198–219. doi:10.1177/2045125314540297
  • Bugarski-Kirola, D., Wang, A., Abi-Saab, D., & Blattler, T. (2014). A phase II/III trial of bitopertin monotherapy compared with placebo in patients with an acute exacerbation of schizophrenia – Results from the CandleLyte study. European Neuropsychopharmacology, 24, 1024–1036. doi:10.1016/j.euroneuro.2014.03.007
  • Cahoon, E. K., McGinty, E. E., Ford, D. E., & Daumit, G. L. (2013). Schizophrenia and potentially preventable hospitalizations in the United States: A retrospective cross-sectional study. BMC Psychiatry, 13, 37. doi:10.1186/1471-244X-13-37
  • Casey, D. E. (2003). Long-term treatment goals: enhancing healthy outcomes. CNS Spectrums, 8, 26–28.
  • Chong, H. Y., Teoh, S. L., Wu, D. B., Kotirum, S., Chiou, C. F., & Chaiyakunapruk, N. (2016). Global economic burden of schizophrenia: A systematic review. Neuropsychiatric Disease and Treatment, 12, 357–373. doi:10.2147/NDT.S96649
  • De la Gandara, J., San Molina, L., Rubio, G., Rodriguez-Morales, A., Hidalgo Borrajo, R., Buron, J. A. (2009). Experience with injectable long-acting risperidone in long-term therapy after an acute episode of schizophrenia: The SPHERE Study. Expert Review of Neurotherapeutics, 9, 1463–1474. doi:10.1586/ern.09.96
  • Degli Esposti, L., Sangiorgi, D., Mencacci, C., Spina, E., Pasina, C., Alacqua, M., & la Tour, F. (2014). Pharmaco-utilisation and related costs of drugs used to treat schizophrenia and bipolar disorder in Italy: The IBIS study. BMC Psychiatry, 14, 282. doi:10.1186/s12888-014-0282-z
  • Diagnostic and Statistical. (2000). Manual of mental disorders (4th ed., Text revision). Washington, DC: American Psychiatric Association.
  • Doshi, J. A., Pettit, A. R., Stoddard, J. J., Zummo, J., & Marcus, S. C. (2015). Concurrent oral antipsychotic drug use among schizophrenia patients initiated on long-acting injectable antipsychotics post-hospital discharge. Journal of Clinical Psychopharmacology, 35, 442–446. doi:10.1097/JCP.0000000000000353
  • Emsley, R., Chiliza, B., Asmal, L., & Harvey, B. H. (2013). The nature of relapse in schizophrenia. BMC Psychiatry, 13, 50. doi:10.1186/1471-244X-13-50
  • Emsley, R., Chiliza, B., Asmal, L., & Lehloenya, K. (2011). The concepts of remission and recovery in schizophrenia. Current Opinion in Psychiatry, 24, 114–121. doi:10.1097/YCO.0b013e3283436ea3
  • Fu, D. J., Bossie, C. A., Sliwa, J. K., Ma, Y. W., & Alphs, L. (2014). Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. International Clinical Psychopharmacology, 29(1), 45–55. doi:10.1097/YIC.0000000000000006
  • Gopal, S., Pandina, G., Lane, R., Nuamah, I., Remmerie, B., Coppola, D., & Hough, D. (2011). A post-hoc comparison of paliperidone palmitate to oral risperidone during initiation of long-acting risperidone injection in patients with acute schizophrenia. Innovations in Clinical Neuroscience, 8, 26–33.
  • Guy, W. (Ed.). (1976). ECDEU assessment manual for psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare. Public Health Service. Alcohol, Drug Abuse, and Mental Health Administration.
  • Haddad, P. M., Kishimoto, T., Correll, C. U., & Kane, J. M. (2015). Ambiguous findings concerning potential advantages of depot antipsychotics: in search of clinical relevance. Current Opinion in Psychiatry, 28, 216–221. doi:10.1097/YCO.0000000000000160
  • Hamann, J., Kissling, W., & Heres, S. (2014). Checking the plausibility of psychiatrists arguments for not prescribing depot medication. European Neuropsychopharmacology, 24, 1506–1510. doi:10.1016/j.euroneuro.2014.06.015
  • Hargarter, L., Cherubin, P., Bergmans, P., Keim, S., Rancans, E., Bez, Y., … Schreiner, A. (2015). Intramuscular long-acting paliperidone palmitate in acute patients with schizophrenia unsuccessfully treated with oral antipsychotics. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 58, 1–7. doi:10.1016/j.pnpbp.2014.11.006
  • Haro, J. M., Kamath, S. A., Ochoa, S., Novick, D., Rele, K., Fargas, A., … Jones, P. (2003). The Clinical Global Impression-Schizophrenia scale: A simple instrument to measure the diversity of symptoms present in schizophrenia. Acta Psychiatrica Scandinavica, 107, 16–23. doi:10.1034/j.1600-0447.107.s416.5.x
  • Harvey, P. D., Loewenstein, D. A., & Czaja, S. J. (2013). Hospitalization and psychosis: Influences on the course of cognition and everyday functioning in people with schizophrenia. Neurobiology of Disease, 53, 18–25. doi:10.1016/j.nbd.2012.10.022
  • Hogan, T. P., Awad, A. G., & Eastwood, R. (1983). A self-report scale predictive of drug compliance in schizophrenics: Reliability and discriminative validity. Psychological Medicine, 13(1), 177–183. doi:10.1017/S0033291700050182
  • Kaplan, G., Casoy, J., & Zummo, J. (2013). Impact of long-acting injectable antipsychotics on medication adherence and clinical, functional, and economic outcomes of schizophrenia. Patient Preference and Adherence, 7, 1171–1180. doi:10.2147/PPA.S53795
  • Karson, C., Duffy, R. A., Eramo, A., Nylander, A. G., & Offord, S. J. (2016). Long-term outcomes of antipsychotic treatment in patients with first-episode schizophrenia: A systematic review. Neuropsychiatric Disease and Treatment, 12, 57–67. doi:10.2147/NDT.S96392
  • Kirschner, M., Theodoridou, A., Fusar-Poli, P., Kaiser, S., & Jager, M. (2013). Patients' and clinicians' attitude towards long-acting depot antipsychotics in subjects with a first episode of psychosis. Therapeutic Advances in Psychopharmacology, 3, 89–99. doi:10.1177/2045125312464106
  • Kishimoto, T., Nitta, M., Borenstein, M., Kane, J. M., & Correll, C. U. (2013). Long-acting injectable versus oral antipsychotics in schizophrenia: A systematic review and meta-analysis of mirror-image studies. The Journal of Clinical Psychiatry, 74, 957–965. doi:10.4088/JCP.13r08440
  • Kishimoto, T., Robenzadeh, A., Leucht, C., Leucht, S., Watanabe, K., Mimura, M., … Correll, C. U. (2014). Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: A meta-analysis of randomized trials. Schizophrenia Bulletin, 40(1), 192–213. doi:10.1093/schbul/sbs150
  • Lafeuille, M. H., Grittner, A. M., Fortier, J., Muser, E., Fasteneau, J., Duh, M. S., & Lefebvre, P. (2015). Comparison of rehospitalization rates and associated costs among patients with schizophrenia receiving paliperidone palmitate or oral antipsychotics. American Journal of Health-System Pharmacy, 72, 378–389. doi:10.2146/ajhp140219
  • Lafeuille, M. H., Laliberte-Auger, F., Lefebvre, P., Frois, C., Fastenau, J., & Duh, M. S. (2013). Impact of atypical long-acting injectable versus oral antipsychotics on rehospitalization rates and emergency room visits among relapsed schizophrenia patients: A retrospective database analysis. BMC Psychiatry, 13, 221. doi:10.1186/1471-244X-13-221
  • Law, M. R., Soumerai, S. B., Ross-Degnan, D., & Adams, A. S. (2008). A longitudinal study of medication nonadherence and hospitalization risk in schizophrenia. The Journal of Clinical Psychiatry, 69(1), 47–53.
  • Li, H., Turkoz, I., & Zhang, F. (2016). Efficacy and safety of once-monthly injection of paliperidone palmitate in hospitalized Asian patients with acute exacerbated schizophrenia: An open-label, prospective, noncomparative study. Neuropsychiatric Disease and Treatment, 12, 15–24. doi:10.2147/NDT.S83651
  • Maia-de-Oliveira, J. P., Bressan, R. A., Elkis, H., Machado-de-Sousa, J. P., & Hallak, J. E. (2013). Why we should use long-acting injectable antipsychotics more frequently. Revista Brasileira de Psiquiatria, 35, 217–218. doi:10.1590/1516-4446-2013-3503
  • Meltzer, H. Y., Cucchiaro, J., Silva, R., Ogasa, M., Phillips, D., Xu, J., … Loebel, A. (2011). Lurasidone in the treatment of schizophrenia: A randomized, double-blind, placebo- and olanzapine-controlled study. American Journal of Psychiatry, 168, 957–967. doi:10.1176/appi.ajp.2011.10060907
  • Mesones-Peral, J. E., Gurillo-Munoz, P., Sanchez-Sicilia, M. P., Miller, A., & Gurinat-Fernandez, A. (2016). Hospitalizations and economic analysis in psychotic patients with paliperidone palmitate long-acting injection. Revista de Psiquiatría y Salud Mental, 10, 33–37. doi:10.1016/j.rpsm.2016.01.011
  • Morosini, P. L., Magliano, L., Brambilla, L., Ugolini, S., & Pioli, R. (2000). 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 Psychiatrica Scandinavica, 101, 323–329. doi:10.1034/j.1600-0447.2000.101004323.x
  • Nasrallah, H. A. (2007). The case for long-acting antipsychotic agents in the post-CATIE era. Acta Psychiatrica Scandinavica, 115, 260–267. doi:10.1111/j.1600-0447.2006.00982.x
  • Overall JEGD. (1962). The brief psychiatric rating scale. Psychological Reports, 10, 799–812.
  • Pandina, G., Lane, R., Gopal, S., Gassmann-Mayer, C., Hough, D., Remmerie, B., & Simpson, G. (2011). A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 35(1), 218–226. doi:10.1016/j.pnpbp.2010.11.008
  • Parellada, E., & Bioque, M. (2016). Barriers to the use of long-acting injectable antipsychotics in the management of schizophrenia. CNS Drugs. 30, 689–701. doi:10.1007/s40263-016-0350-7
  • Robinson, D., Woerner, M. G., Alvir, J. M., Bilder, R., Goldman, R., Geisler, S., …Lieberman, J. A. (1999). Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Archives of General Psychiatry. 56, 241–247. doi:10.1001/archpsyc.56.3.241
  • Samtani, M. N., Gopal, S., Gassmann-Mayer, C., Alphs, L., & Palumbo, J. M. (2011). Dosing and switching strategies for paliperidone palmitate: Based on population pharmacokinetic modelling and clinical trial data. CNS Drugs. 25, 829–845. doi:10.2165/11591690-000000000-00000
  • Schreiner, A., Aadamsoo, K., Altamura, A. C., Franco, M., Gorwood, P., Neznanov, N. G., … Hargarter, L. (2015). Paliperidone palmitate versus oral antipsychotics in recently diagnosed schizophrenia. Schizophrenia Research, 169(1–3), 393–399. doi:10.1016/j.schres.2015.08.015
  • Taylor, D., & Olofinjana, O. (2014). Long-acting paliperidone palmitate – Interim results of an observational study of its effect on hospitalization. International Clinical Psychopharmacology, 29, 229–234. doi:10.1097/YIC.0000000000000028
  • World Medical A. (2013). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA. 310, 2191–2194. doi:10.1001/jama.2013.281053
  • Xeplion. Summary of product characteristics. Retrieved May 3, 2016 From http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002105/WC500103317.pdf
  • Zhang, F., Si, T., Chiou, C. F., Harris, A. W., Kim, C. Y., Jahagirdar, P., & Ascher, S. (2015). Efficacy, safety, and impact on hospitalizations of paliperidone palmitate in recent-onset schizophrenia. Neuropsychiatric Disease and Treatment, 11, 657–668. doi:10.2147/NDT.S77778

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