A Long-Term Safety and Tolerability Study of TV-46000 for Subcutaneous Use in Patients with Schizophrenia: A Phase 3, Randomized, Double-Blinded Clinical Trial

Hjorthøj C, Stürup AE, McGrath JJ, Nordentoft M. Years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis. Lancet Psychiatry. 2017;4(4):295–301.

Article  PubMed  Google Scholar 

Kahn RS, Sommer IE, Murray RM, Meyer-Lindenberg A, Weinberger DR, Cannon TD, et al. Schizophrenia. Nat Rev Dis Primers. 2015;1:15067.

Article  PubMed  Google Scholar 

Correll CU, Solmi M, Croatto G, Schneider LK, Rohani-Montez SC, Fairley L, et al. Mortality in people with schizophrenia: a systematic review and meta-analysis of relative risk and aggravating or attenuating factors. World Psychiatry. 2022;21(2):248–71.

Article  PubMed  PubMed Central  Google Scholar 

McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemiol Rev. 2008;30:67–76.

Article  PubMed  Google Scholar 

Perälä J, Suvisaari J, Saarni SI, Kuoppasalmi K, Isometsä E, Pirkola S, et al. Lifetime prevalence of psychotic and bipolar I disorders in a general population. Arch Gen Psychiatry. 2007;64(1):19–28.

Article  PubMed  Google Scholar 

Jerrell JM, McIntyre RS. Factors differentiating childhood-onset and adolescent-onset schizophrenia: a claims database study. Prim Care Companion CNS Disord. 2016. https://doi.org/10.4088/PCC.15m01901.

Article  PubMed  PubMed Central  Google Scholar 

Correll CU, Rubio JM, Kane JM. What is the risk-benefit ratio of long-term antipsychotic treatment in people with schizophrenia? World Psychiatry. 2018;17(2):149–60.

Article  PubMed  PubMed Central  Google Scholar 

Fountoulakis KN, Moeller HJ, Kasper S, Tamminga C, Yamawaki S, Kahn R, et al. The report of the joint WPA/CINP workgroup on the use and usefulness of antipsychotic medication in the treatment of schizophrenia. CNS Spectr. 2020;1–25

Catalan A, Richter A, Salazar de Pablo G, Vaquerizo-Serrano J, Mancebo G, Pedruzo B, et al. Proportion and predictors of remission and recovery in first-episode psychosis: systematic review and meta-analysis. Eur Psychiatry. 2021;64(1): e69.

Article  PubMed  PubMed Central  Google Scholar 

Carbon M, Correll CU. Clinical predictors of therapeutic response to antipsychotics in schizophrenia. Dialogues Clin Neurosci. 2014;16(4):505–24.

Article  PubMed  PubMed Central  Google Scholar 

Hansen HG, Speyer H, Starzer M, Albert N, Hjorthøj C, Eplov LF, et al. Clinical recovery among individuals with a first-episode schizophrenia an updated systematic review and meta-analysis. Schizophr Bull. 2023;49(2):297–308.

Article  PubMed  Google Scholar 

Takeuchi H, Siu C, Remington G, Fervaha G, Zipursky RB, Foussias G, et al. Does relapse contribute to treatment resistance? Antipsychotic response in first- vs. second-episode schizophrenia. Neuropsychopharmacology. 2019;44(6):1036–42.

Article  CAS  PubMed  Google Scholar 

Taipale H, Tanskanen A, Correll CU, Tiihonen J. Real-world effectiveness of antipsychotic doses for relapse prevention in patients with first-episode schizophrenia in Finland: a nationwide, register-based cohort study. Lancet Psychiatry. 2022;9(4):271–9.

Article  PubMed  Google Scholar 

Zipursky RB, Agid O, Remington G. Improving outcomes in schizophrenia by preventing early relapses. Lancet Psychiatry. 2018;5(5):384–6.

Article  PubMed  Google Scholar 

Lin D, Joshi K, Keenan A, Shepherd J, Bailey H, Berry M, et al. Associations between relapses and psychosocial outcomes in patients with schizophrenia in real-world settings in the United States. Front Psychiatry. 2021;12: 695672.

Article  PubMed  PubMed Central  Google Scholar 

Robinson D, Woerner MG, Alvir JM, Bilder R, Goldman R, Geisler S, et al. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 1999;56(3):241–7.

Article  CAS  PubMed  Google Scholar 

Bodén R, Brandt L, Kieler H, Andersen M, Reutfors J. Early non-adherence to medication and other risk factors for rehospitalization in schizophrenia and schizoaffective disorder. Schizophr Res. 2011;133(1–3):36–41.

Article  PubMed  Google Scholar 

Kane JM, Kishimoto T, Correll CU. Non-adherence to medication in patients with psychotic disorders: epidemiology, contributing factors and management strategies. World Psychiatry. 2013;12(3):216–26.

Article  PubMed  PubMed Central  Google Scholar 

Greene M, Yan T, Chang E, Hartry A, Touya M, Broder MS. Medication adherence and discontinuation of long-acting injectable versus oral antipsychotics in patients with schizophrenia or bipolar disorder. J Med Econ. 2018;21(2):127–34.

Article  PubMed  Google Scholar 

Kishimoto T, Hagi K, Kurokawa S, Kane JM, Correll CU. Long-acting injectable versus oral antipsychotics for the maintenance treatment of schizophrenia: a systematic review and comparative meta-analysis of randomised, cohort, and pre-post studies. Lancet Psychiatry. 2021;8(5):387–404.

Article  PubMed  Google Scholar 

Pilon D, Joshi K, Tandon N, Lafeuille MH, Kamstra RL, Emond B, et al. Treatment patterns in Medicaid patients with schizophrenia initiated on a first- or second-generation long-acting injectable versus oral antipsychotic. Patient Prefer Adherence. 2017;11:619–29.

Article  PubMed  PubMed Central  Google Scholar 

Subotnik KL, Casaus LR, Ventura J, Luo JS, Hellemann GS, Gretchen-Doorly D, et al. Long-acting injectable risperidone for relapse prevention and control of breakthrough symptoms after a recent first episode of schizophrenia. A randomized clinical trial. JAMA Psychiat. 2015;72(8):822–9.

Article  Google Scholar 

Rubio JM, Taipale H, Tanskanen A, Correll CU, Kane JM, Tiihonen J. Long-term continuity of antipsychotic treatment for schizophrenia: a nationwide study. Schizophr Bull. 2021;47(6):1611–20.

Article  PubMed  PubMed Central  Google Scholar 

Tiihonen J, Haukka J, Taylor M, Haddad PM, Patel MX, Korhonen P. A nationwide cohort study of oral and depot antipsychotics after first hospitalization for schizophrenia. Am J Psychiatry. 2011;168(6):603–9.

Article  PubMed  Google Scholar 

Kane JM, Schooler NR, Marcy P, Correll CU, Achtyes ED, Gibbons RD, et al. Effect of long-acting injectable antipsychotics vs usual care on time to first hospitalization in early-phase schizophrenia: a randomized clinical trial. JAMA Psychiat. 2020;77(12):1217–24.

Article  Google Scholar 

Brown B, Turkoz I, Mancevski B, Mathews M. Evaluation of paliperidone palmitate long-acting injectable antipsychotic therapy as an early treatment option in patients with schizophrenia. Early Interv Psychiatry. 2020;14(4):428–38.

Article  PubMed  Google Scholar 

Emsley R, Medori R, Koen L, Oosthuizen PP, Niehaus DJ, Rabinowitz J. Long-acting injectable risperidone in the treatment of subjects with recent-onset psychosis: a preliminary study. J Clin Psychopharmacol. 2008;28(2):210–3.

Article  CAS  PubMed  Google Scholar 

Girardi P, Del Casale A, Rapinesi C, Kotzalidis GD, Splendori F, Verzura C, et al. Predictive factors of overall functioning improvement in patients with chronic schizophrenia and schizoaffective disorder treated with paliperidone palmitate and aripiprazole monohydrate. Hum Psychopharmacol. 2018;33(3): e2658.

Article  PubMed  Google Scholar 

Hargarter L, Bergmans P, Cherubin P, Keim S, Conca A, Serrano-Blanco A, et al. Once-monthly paliperidone palmitate in recently diagnosed and chronic non-acute patients with schizophrenia. Expert Opin Pharmacother. 2016;17(8):1043–53.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ohnishi T, Kobayashi H, Yamaoka T, Toma T, Imai K, Wakamatsu A, et al. The effects of paliperidone palmitate 1 month on the employment status and social functioning of patients with schizophrenia. Innov Clin Neurosci. 2020;17(1–3):36–44.

PubMed  PubMed Central  Google Scholar 

Phahladira L, Luckhoff HK, Asmal L, Kilian S, Scheffler F, Plessis SD, et al. Early recovery in the first 24 months of treatment in first-episode schizophrenia-spectrum disorders. NPJ Schizophr. 2020;6(1):2.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kane JM, Mychaskiw MA, Lim S, Suett M, Tian M, Rubio JM. Treatment journey from diagnosis to the successful implementation of a long-acting injectable antipsychotic agent in young adults with schizophrenia. J Clin Psychiatry. 2023;84(3):22m14544.

Article  PubMed  Google Scholar

Comments (0)

No login
gif