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Clinical Trial Report

Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies

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Pages 1411-1426 | Published online: 08 Jun 2020

References

  • Sharma A, Couture J. A review of the pathophysiology, etiology, and treatment of attention-deficit hyperactivity disorder (ADHD). Ann Pharmacother. 2014;48(2):209–225. doi:10.1177/106002801351069924259638
  • Berridge CW, Devilbiss DM, Andrzejewski ME, et al. Methylphenidate preferentially increases catecholamine neurotransmission within the prefrontal cortex at low doses that enhance cognitive function. Biol Psychiatry. 2006;60(10):1111–1120. doi:10.1016/j.biopsych.2006.04.02216806100
  • Levy F. Dopamine vs noradrenaline: inverted-U effects and ADHD theories. Aust N Z J Psychiatry. 2009;43(2):101–108. doi:10.1080/0004867080260723819153917
  • Cortese S, Adamo N, Mohr-Jensen C, et al. Comparative efficacy and tolerability of medications for attention deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. Lancet Psych. 2018;5(9):727–738. doi:10.1016/S2215-0366(18)30269-4
  • Heal DJ, Smith SL, Gosden J, Nutt DJ. Amphetamine, past and present–a pharmacological and clinical perspective. J Psychopharmacol. 2013;27(6):479–496. doi:10.1177/026988111348253223539642
  • Heal DJ, Smith SL, Henningfield JE. CNS stimulants. Neuropharmacology. 2014;87:1–3. doi:10.1016/j.neuropharm.2014.09.02525278034
  • Kolar D, Keller A, Golfinopoulos M, Cumyn L, Hechtman L, Hechtman L. Treatment of adults with attention-deficit/hyperactivity disorder. Neuropsychiatr Dis Treat. 2008;4(1):107–121. doi:10.2147/ndt.s174718728812
  • Substance Abuse and Mental Health Services Administration. Results from the 2017 national survey on drug use and health: detailed tables. Available at: https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.htm#tab1-25D. Accessed 515, 2020 Accessed 5 17, 2019.
  • Bright GM. Abuse of medications employed for the treatment of ADHD: results from a large-scale community survey. Medscape J Med. 2008;10:111.18596945
  • Upadhyaya H, Tanaka Y, Lipsius S, et al. Time-to-onset and -resolution in adult patients with ADHD. Postgrad Med. 2015;127(7):677–685. doi:10.1080/00325481.2015.108339426329980
  • Atomoxetine [Package Insert]. Indianapolis, IN: Eli Lilly & Co; 2017.
  • Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014;24(8):426–434. doi:10.1089/cap.2014.000525019647
  • Chan E, Fogler JM, Hammerness PG. Treatment of attention-deficit/hyperactivity disorder in adolescents: a systematic review. JAMA. 2016;315(18):1997–2008. doi:10.1001/jama.2016.545327163988
  • Sallee FR, Lyne A, Wigal T, McGough JJ. McGough. Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009;19(3):215–226. doi:10.1089/cap.2008.008019519256
  • Bymaster FP, Golembiowska K, Kowalska M, Choi YK, Tarazi FI. Pharmacologic characterization of the norepinephrine and dopamine reuptake inhibitor EB-1020: implications for treatment of attention-deficit Hypersensitivity disorder. Synapse. 2012;66(6):522–532. doi:10.1002/syn.2153822298359
  • Schoedel KA, Meier D, Chakraborty B, Manniche PM, Sellers EM. Subjective and objective effects of the novel triple reuptake inhibitor tesofensine in recreational stimulant users. Clin Pharmacol Ther. 2010;88(1):69–78. doi:10.1038/clpt.2010.6720520602
  • Learned S, Graff O, Bye A, et al. A novel double blind, placebo-controlled, modified crossover study to assess the abuse potential of GSK372475 in comparison with d-amphetamine and pseudoephedrine in healthy adult, experienced stimulant drug users. Poster presented at: 2010. Ann Meeting Am Soc Clin Pharmacol Ther. 2010;87.
  • Griffith JD, Carranza J, Griffith C, Miller LL. Bupropion: clinical assay for amphetamine-like abuse potential. J Clin Psychiatry. 1983;44(5 Pt 2):206–208.6406459
  • American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Washington, DC: American Psychiatric Publishing; 1994.
  • American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth ed. Arlington, VA: American Psychiatric Publishing; 2013.
  • Swanson JM, Agler D, Fineberg E, et al. UCI laboratory school protocol for PK/PD studies In: Greenhill LL, Osman BB, editors. Ritalin: Theory and Practice, Second Larchmont, NY: Mary Ann Liebert; 2000:405–430.
  • Wigal SB, Wigal TL. The laboratory school protocol: its origin, use, and new applications. J Atten Disord. 2006;10(1):92–111. doi:10.1177/108705470528604916840597
  • Wigal SB. Laboratory school protocol mini-review: use of direct observational and objective measures to assess ADHD treatment response across the lifespan. Front Psychol. 2019;10:1796. doi:10.3389/fpsyg.2019.0179631496966
  • US Department of Health and Human Services, Food and Drug Administration, Centers for Drug Evaluation and Research (CDER). Assessment of abuse potential of drugs: guidance for industry. 1 2017 Available at: https://www.fda.gov/downloads/drugs/guidances/ucm198650.pdf. Accessed 517, 2019.
  • Faraone SV, Glatt SJ. A comparison of the efficacy of medications for adult attention-deficit/hyperactivity disorder using meta-analysis of effect sizes. J Clin Psychiatry. 2010;71(06):754–763. doi:10.4088/JCP.08m04902pur20051220
  • Wynchank D, Bijlenga D, Beekman AT, Kooij JJS, Penninx BW. Adult attention-deficit/hyperactivity disorder (ADHD) and insomnia: an update of the literature. Curr Psychiatr Rep. 2017;30(12):98. doi:10.1007/s11920-017-0860-0
  • Wigal SB, Wigal T, Leoni M, et al. A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Crossover, Safety and Efficacy Study of Centanafadine Sustained-Release in Adults with Attention-Deficit Hyperactivity Disorder. Presented At: 2019 Annual Meeting of the American Professional Society of ADHD and Related Disorders. 1 18–20, 2019 Washington, DC poster S4.
  • Volkow ND, Swanson JM. Variables that affect the clinical use and abuse of methylphenidate in the treatment of ADHD. Am J Psychiatry. 2003;160(11):1909–1918. doi:10.1176/appi.ajp.160.11.190914594733