Rapastinel - an investigational NMDA-R modulator for major depressive disorder: evidence to date

References

• World Health Organization. Depression. 2017 [cited 2018 Mar 15]. Available from https://www.who.int/en/news-room/fact-sheets/detail/depression.
   Google Scholar
• Ferrari AJ, Somerville AJ, Baxter AJ, et al. Global variation in the prevalence and incidence of major depressive disorder: a systematic review of the epidemiological literature. Psychol Med. 2013 Mar;43(3):471–481. PubMed PMID: 22831756.
   PubMed Web of Science ®Google Scholar
• Olfson M, Marcus SC. National patterns in antidepressant medication treatment. Arch Gen Psychiatry. 2009 Aug;66(8):848–856. PubMed PMID: 19652124.
   PubMed Web of Science ®Google Scholar
• Mrazek DA, Hornberger JC, Altar CA, et al. A review of the clinical, economic, and societal burden of treatment-resistant depression: 1996–2013. Psychiatric Serv. 2014 Aug 1;65(8):977–987. PubMed PMID: 24789696.
   PubMed Web of Science ®Google Scholar
• Sheehan DV, Harnett-Sheehan K, Spann ME, et al. Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale. Int Clin Psychopharmacol. 2011 Mar;26(2):75–83. PubMed PMID: 21102344.
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Lee Y, Mansur RB. Treating to target in major depressive disorder: response to remission to functional recovery. CNS Spectr. 2015 Dec;20(Suppl 1):20–30; quiz 31. PubMed PMID: 26683526.
   PubMedGoogle Scholar
• Moret C. Combination/augmentation strategies for improving the treatment of depression. Neuropsychiatr Dis Treat. 2005 Dec;1(4):301–309. PubMed PMID: 18568111; PubMed Central PMCID: PMC2424118.
   PubMedGoogle Scholar
• Nelson JC, Papakostas GI. Atypical antipsychotic augmentation in major depressive disorder: a meta-analysis of placebo-controlled randomized trials. Am J Psychiatry. 2009 Sep;166(9):980–991. PubMed PMID: 19687129.
   PubMed Web of Science ®Google Scholar
• Wang HR, Woo YS, Ahn HS, et al. Can atypical antipsychotic augmentation reduce subsequent treatment failure more effectively among depressed patients with a higher degree of treatment resistance? A meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol/Official Sci J Collegium Int Neuropsychopharmacologicum. 2015 Mar 13;18(8). PubMed PMID: 25770098; PubMed Central PMCID: PMC4571632. DOI:10.1093/ijnp/pyv023
   Google Scholar
• de Sousa RT, Zanetti MV, Brunoni AR, et al. Challenging treatment-resistant major depressive disorder: a roadmap for improved therapeutics. Curr Neuropharmacol. 2015;13(5):616–635. PubMed PMID: 26467411; PubMed Central PMCID: PMC4761633.
   PubMed Web of Science ®Google Scholar
• Katz MM, Tekell JL, Bowden CL, et al. Onset and early behavioral effects of pharmacologically different antidepressants and placebo in depression. Neuropsychopharmacol. 2004 Mar;29(3):566–579. PubMed PMID: 14627997.
   PubMed Web of Science ®Google Scholar
• Smith KA, Cipriani A. Lithium and suicide in mood disorders: updated meta-review of the scientific literature. Bipolar Disord. 2017 Nov;19(7):575–586. PubMed PMID: 28895269.
   PubMed Web of Science ®Google Scholar
• Hennen J, Baldessarini RJ. Suicidal risk during treatment with clozapine: a meta-analysis. Schizophr Res. 2005 Mar 1;73(2–3):139–145. PubMed PMID: 15653256.
   PubMed Web of Science ®Google Scholar
• Sanacora G, Treccani G, Popoli M. Towards a glutamate hypothesis of depression: an emerging frontier of neuropsychopharmacology for mood disorders. Neuropharmacology. 2012 Jan;62(1):63–77. PubMed PMID: 21827775; PubMed Central PMCID: PMC3205453.
   PubMed Web of Science ®Google Scholar
• Autry AE, Adachi M, Nosyreva E, et al. NMDA receptor blockade at rest triggers rapid behavioural antidepressant responses. Nature. 2011 Jun 15;475(7354):91–95. PubMed PMID: 21677641; PubMed Central PMCID: PMC3172695.
   PubMed Web of Science ®Google Scholar
• Gibbons AS, Brooks L, Scarr E, et al. AMPA receptor expression is increased post-mortem samples of the anterior cingulate from subjects with major depressive disorder. J Affect Disord. 2012 Feb;136(3):1232–1237. PubMed PMID: 22036795; PubMed Central PMCID: PMC3275646.
   PubMed Web of Science ®Google Scholar
• Murrough JW, Iosifescu DV, Chang LC, et al. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134–1142. PubMed PMID: 23982301; PubMed Central PMCID: PMC3992936.
   PubMed Web of Science ®Google Scholar
• Coyle CM, Laws KR. The use of ketamine as an antidepressant: a systematic review and meta-analysis. Hum Psychopharmacol. 2015 May;30(3):152–163. PubMed PMID: 25847818.
   PubMed Web of Science ®Google Scholar
• Short B, Fong J, Galvez V, et al. Side-effects associated with ketamine use in depression: a systematic review. Lancet Psychiatry. 2018 Jan;5(1):65–78. PubMed PMID: 28757132.
   PubMed Web of Science ®Google Scholar
• Preskorn S, Macaluso M, Mehra DO, et al. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140–149. PubMed PMID: 25782764.
   PubMed Web of Science ®Google Scholar
• Kato T, Fogaca MV, Deyama S, et al. BDNF release and signaling are required for the antidepressant actions of GLYX-13. Mol Psychiatry. 2017 Dec 5. PubMed PMID: 29203848; PubMed Central PMCID: PMC5988860. DOI:10.1038/mp.2017.220
   Web of Science ®Google Scholar
• Yang B, Zhang JC, Han M, et al. Comparison of R-ketamine and rapastinel antidepressant effects in the social defeat stress model of depression. Psychopharmacology (Berl). 2016 Oct;233(19–20):3647–3657. PubMed PMID: 27488193; PubMed Central PMCID: PMC5021744.
   PubMed Web of Science ®Google Scholar
• Duman RS. Pathophysiology of depression and innovative treatments: remodeling glutamatergic synaptic connections. Dialogues Clin Neurosci. 2014 Mar;16(1):11–27. PubMed PMID: 24733968; PubMed Central PMCID: PMC3984887.
   PubMed Web of Science ®Google Scholar
• Widman AJ, McMahon LL. Disinhibition of CA1 pyramidal cells by low-dose ketamine and other antagonists with rapid antidepressant efficacy. Proc Natl Acad Sci U S A. 2018 Mar 27;115(13):E3007–E3016. PubMed PMID: 29531088; PubMed Central PMCID: PMC5879689.
   PubMed Web of Science ®Google Scholar
• Lepack AE, Bang E, Lee B, et al. Fast-acting antidepressants rapidly stimulate ERK signaling and BDNF release in primary neuronal cultures. Neuropharmacology. 2016 Dec;111:242–252. PubMed PMID: 27634096; PubMed Central PMCID: PMC5075989.
   PubMed Web of Science ®Google Scholar
• Koike H, Iijima M, Chaki S. Involvement of the mammalian target of rapamycin signaling in the antidepressant-like effect of group II metabotropic glutamate receptor antagonists. Neuropharmacology. 2011 Dec;61(8):1419–1423. PubMed PMID: 21903115.
   PubMed Web of Science ®Google Scholar
• Lu Y, Wang C, Xue Z, et al. PI3K/AKT/mTOR signaling-mediated neuropeptide VGF in the hippocampus of mice is involved in the rapid onset antidepressant-like effects of GLYX-13. Int J Neuropsychopharmacology/Official Sci J Collegium Int Neuropsychopharmacologicum. 2014 Dec 25;18(5). PubMed PMID: 25542689; PubMed Central PMCID: PMC4376553. DOI:10.1093/ijnp/pyu110
   Google Scholar
• Burgdorf J, Zhang XL, Weiss C, et al. The long-lasting antidepressant effects of rapastinel (GLYX-13) are associated with a metaplasticity process in the medial prefrontal cortex and hippocampus. Neuroscience. 2015 Nov 12;308:202–211. PubMed PMID: 26343295; PubMed Central PMCID: PMC4721228.
   PubMed Web of Science ®Google Scholar
• Burgdorf J, Zhang XL, Nicholson KL, et al. GLYX-13, a NMDA receptor glycine-site functional partial agonist, induces antidepressant-like effects without ketamine-like side effects. Neuropsychopharmacol. 2013 Apr;38(5):729–742. PubMed PMID: 23303054; PubMed Central PMCID: PMC3671991.
   PubMed Web of Science ®Google Scholar
• Rajagopal L, Burgdorf JS, Moskal JR, et al. GLYX-13 (rapastinel) ameliorates subchronic phencyclidine- and ketamine-induced declarative memory deficits in mice. Behav Brain Res. 2016 Feb 15;299:105–110. PubMed PMID: 26632337; PubMed Central PMCID: PMC4721234.
   PubMed Web of Science ®Google Scholar
• Thase ME, Rush AJ. When at first you don’t succeed: sequential strategies for antidepressant nonresponders. J Clin Psychiatry. 1997;58(Suppl 13):23–29. PubMed PMID: 9402916.
   PubMed Web of Science ®Google Scholar