Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with bipolar I disorder in a randomized, open-label, parallel-arm, pivotal study

References

• American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. text rev. Washington (DC): American Psychiatric Association; 2022.
   Google Scholar
• McIntyre RS, Berk M, Brietzke E, et al. Bipolar disorders. Lancet. 2020;396(10265):1841–1856.
   PubMed Web of Science ®Google Scholar
• Vázquez GH, Holtzman JN, Lolich M, et al. Recurrence rates in bipolar disorder: systematic comparison of long-term prospective, naturalistic studies versus randomized controlled trials. Eur Neuropsychopharmacol. 2015;25(10):1501–1512.
   PubMed Web of Science ®Google Scholar
• Yatham LN, Kennedy SH, Parikh SV, et al. Canadian network for mood and anxiety treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord. 2018;20(2):97–170.
   PubMed Web of Science ®Google Scholar
• Jawad I, Watson S, Haddad PM, et al. Medication nonadherence in bipolar disorder: a narrative review. Ther Adv Psychopharmacol. 2018;8(12):349–363.
   PubMed Web of Science ®Google Scholar
• Yan T, Greene M, Chang E, et al. Medication adherence and discontinuation of aripiprazole once-monthly 400 mg (AOM 400) versus oral antipsychotics in patients with schizophrenia or bipolar I disorder: a real-world study using US claims data. Adv Ther. 2018;35(10):1612–1625.
   PubMed Web of Science ®Google Scholar
• Lähteenvuo M, Tanskanen A, Taipale H, et al. Real-world effectiveness of pharmacologic treatments for the prevention of rehospitalization in a Finnish nationwide cohort of patients with bipolar disorder. JAMA Psychiatry. 2018;75(4):347–355.
   PubMed Web of Science ®Google Scholar
• Kishi T, Oya K, Iwata N. Long-acting injectable antipsychotics for prevention of relapse in bipolar disorder: a systematic review and meta-analyses of randomized controlled trials. Int J Neuropsychopharmacol. 2016;19(9):pyw038.
   PubMed Web of Science ®Google Scholar
• Abilify Maintena® (aripiprazole). Prescribing Information. Rockville (MD): Otsuka America Pharmaceutical, Inc.; 2020.
   Google Scholar
• Abilify Maintena® (aripiprazole). Summary of product characteristics. Amsterdam (Netherlands): Otsuka Pharmaceutical Netherlands B.V.; 2021.
   Google Scholar
• Calabrese JR, Jin N, Johnson B, et al. Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study. Int J Bipolar Disord. 2018;6(1):14.
   PubMed Web of Science ®Google Scholar
• Calabrese JR, Sanchez R, Jin N, et al. Efficacy and safety of aripiprazole once-monthly in the maintenance treatment of bipolar I disorder: a double-blind, placebo-controlled, 52-week randomized withdrawal study. J Clin Psychiatry. 2017;78(3):324–331.
   PubMed Web of Science ®Google Scholar
• Citrome L. Long-acting injectable antipsychotics update: lengthening the dosing interval and expanding the diagnostic indications. Expert Rev Neurother. 2017;17(10):1029–1043.
   PubMed Web of Science ®Google Scholar
• Citrome L. Long-acting injectable antipsychotics: what, when, and how. CNS Spectr. 2021;26(2):118–129.
   Web of Science ®Google Scholar
• Jawad MY, McIntyre RS. Barriers to managing bipolar I disorder with long-acting injectable antipsychotics. Eur Neuropsychopharmacol. 2022;64:4–6.
   PubMed Web of Science ®Google Scholar
• Tohen M, Goldberg JF, Hassoun Y, et al. Identifying profiles of patients with bipolar I disorder who would benefit from maintenance therapy with a long-acting injectable antipsychotic. J Clin Psychiatry. 2020;81(4):OT19046AH1.
   PubMed Web of Science ®Google Scholar
• Harlin M, Yildirim M, Such P, et al. A randomized, open-label, multiple-dose, parallel-arm, pivotal study to evaluate the safety, tolerability, and pharmacokinetics of aripiprazole 2-month long-acting injectable in adults with schizophrenia or bipolar I disorder. CNS Drugs. 2023;37(4):337–350.
   PubMed Web of Science ®Google Scholar
• Citrome L, Such P, Yildirim M, et al. Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with schizophrenia in a randomized, open-label, parallel-arm, pivotal study. 2023. 23 p.
   Google Scholar
• American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013.
   Google Scholar
• Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266–1277.
   PubMed Web of Science ®Google Scholar
• Delgado DA, Lambert BS, Boutris N, et al. Validation of digital visual analog scale pain scoring with a traditional paper-based visual analog scale in adults. J Am Acad Orthop Surg Glob Res Rev. 2018;2(3):e088.
   PubMedGoogle Scholar
• Simpson GM, Angus JWS. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl. 1970;212:11–19.
   PubMedGoogle Scholar
• Guy W. ECDEU assessment manual for psychopharmacology. Rockville (MD): National Institute of Mental Health; 1976.
   Google Scholar
• Barnes TRE. A rating scale for drug-induced akathisia. Br J Psychiatry. 1989;154(5):672–676.
   PubMed Web of Science ®Google Scholar
• Young RC, Biggs JT, Ziegler VE, et al. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133(5):429–435.
   PubMed Web of Science ®Google Scholar
• Montgomery SA, Åsberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134(4):382–389.
   PubMed Web of Science ®Google Scholar
• Spearing MK, Post RM, Leverich GS, et al. Modification of the clinical global impressions (CGI) scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res. 1997;73(3):159–171.
   PubMed Web of Science ®Google Scholar
• Naber D, Moritz S, Lambert M, et al. Improvement of schizophrenic patients’ subjective well-being under atypical antipsychotic drugs. Schizophr Res. 2001;50(1–2):79–88.
   PubMed Web of Science ®Google Scholar
• Altman DG. Comparability of randomised groups. Statistician. 1985;34(1):125–136.
   Google Scholar
• Food & Drug Administration. What is a serious adverse event? 2016. https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
   Google Scholar
• Shah N, Grover S, Rao GP. Clinical practice guidelines for management of bipolar disorder. Indian J Psychiatry. 2017;59(Suppl 1):S51–S66.
   PubMed Web of Science ®Google Scholar
• Boyer L, Baumstarck K, Boucekine M, et al. Measuring quality of life in patients with schizophrenia: an overview. Expert Rev Pharmacoecon Outcomes Res. 2013;13(3):343–349.
   PubMed Web of Science ®Google Scholar
• Mauriño J, Cordero L, Ballesteros J. The subjective well-being under neuroleptic scale – short version (SWN-K) and the SF-36 health survey as quality of life measures in patients with schizophrenia. Patient Prefer Adherence. 2012;6:83–85.
   PubMed Web of Science ®Google Scholar
• Chakrabarti S. Treatment-adherence in bipolar disorder: a patient-centred approach. World J Psychiatry. 2016;6(4):399–409.
   PubMed Web of Science ®Google Scholar
• Malhi GS, McAulay C, Das P, et al. Maintaining mood stability in bipolar disorder: a clinical perspective on pharmacotherapy. Evid Based Ment Health. 2015;18(1):1–6.
   PubMedGoogle Scholar
• Pacchiarotti I, Tiihonen J, Kotzalidis GD, et al. Long-acting injectable antipsychotics (LAIs) for maintenance treatment of bipolar and schizoaffective disorders: a systematic review. Eur Neuropsychopharmacol. 2019;29(4):457–470.
   PubMed Web of Science ®Google Scholar
• Correll CU, Citrome L, Haddad PM, et al. The use of long-acting injectable antipsychotics in schizophrenia: evaluating the evidence. J Clin Psychiatry. 2016;77(suppl 3):1–24.
   PubMed Web of Science ®Google Scholar
• Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017. Pharmacopsychiatry. 2018;51(1–2):9–62.
   PubMed Web of Science ®Google Scholar
• Manja V, Lakshminrusimha S. Epidemiology and clinical research design, part 1: study types. NeoReviews. 2014;15(12):e558–e569.
   PubMedGoogle Scholar