Innovations In Clinical Neuroscience

ISCTM Supplement 2015

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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[ V O L U M E 1 2 , N U M B E R 3 – 4 , S U P P L E M E N T A , M A R C H – A P R I L 2 0 1 5 ] Innovations in CLINICAL NEUROSCIENCE 25S dose ranges and safety profiles in humans prior to beginning these investigations may also lead to great benefits with agents making it to m arket and staying there. ACKNOWLEDGMENTS We thank Ashish Duggar, PhD, Judith Dunn, PhD, and Richard Keefe, PhD, for their contributing comments and manuscript edits. REFERENCES 1. Fell MJ, Perry KW, Falcone JF, et al. In vitro and in vivo evidence for a lack of interaction with dopamine D 2 receptors by the metabotropic glutamate 2/3 receptor agonists 1S,2S,5R,6S-2- aminobicyclo[3.1.0]hexane-2,6- bicaroxylate monohydrate (LY354740) and (-)-2-Oxa-4- aminobicyclo[3.1.0] Hexane-4,6- dicarboxylic acid (LY379268). J Pharmacol Exp Ther. 2009;331(3):1126–1136. 2. McKinzie, DL, Fell, MJ, Johnson, BG, et al. Synergistic interactions of the mGlu2/3 receptor agonist LY404039 with antipsychotic agents in behavioral and neurochemical animal models predictive of antipsychotic efficacy. Schizophr Bull. 2011;37:110. 3. Patil ST, Zhang L, Martenyi F, et al. Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: a randomized Phase 2 clinical trial. Nat Med. 2007;13(9):1102–1107. 4. Kinon BJ, Zhang L, Millen BA, et al; HBBI Study Group. A multicenter, inpatient, phase 2, double-blind, placebo-controlled dose-ranging study of LY2140023 monohydrate in patients with DSM-IV schizophrenia. J Clin Psychopharmacol. 2011;31(3):349–355. 5. Adams DH, Kinon BJ, Baygani S, et al. A long-term, phase 2, multicenter, randomized, open-label, comparative safety study of pomaglumetad methionil (LY2140023 monohydrate) versus atypical antipsychotic standard of care in patients with schizophrenia. BMC Psychiatry. 2013;13:143. 6. Liu W, Downing AC, Munsie LM, et al. Pharmacogenetic analysis of the mGlu2/3 agonist LY2140023 monohydrate in the treatment of schizophrenia. Pharmacogenomics J. 2012;12(3):246–254. 7. Nisenbaum LK, Zhao F, Downing AM, et al. Confirmation of association between genetic markers in 5HTR2A and response to mGLU2/3 agonist LY2140023 monohydrate in schizophrenia. Eur Neuropsychopharm. 2011; 21(Suppl 3):S233–S244. 8. Downing AM, Kinon BJ, Millen BA, et al. A double-blind, placebo- controlled comparator study of LY2140023 monohydrate in patients with schizophrenia. BMC Psychiatry. 2014;14:351 doi:10.1186/s12888-014-0351-3. 9. Stauffer VL, Millen BA, Andersen S, et al. Pomaglumetad methionil: no significant difference as an adjunctive treatment for patients with prominent negative symptoms of schizophrenia compared to placebo. Schizophr Res. 2013;150(2–3):434–441. 10. Kinon BJ, Millen BA, Zhang L, McKinzie DL. Exploratory analysis for a targeted patient population responsive to the metabotropic glutamate 2/3 receptor agonist pomaglumetad methionil in schizophrenia. Biol Psychiatry March 2015. In press. 11. Kurita M, Holloway T, García-Bea A, et al. HDAC2 regulates atypical antipsychotic responses through the modulation of mGlu2 promoter activity. Nat Neurosci. 2012;(9):1245–1254. 12. Nisenbaum LK, Millen BA, Zhao F, et al. LY2140023 monohydrate in the treatment of patients with schizophrenia: pharmacogenetic analysis within a clinical trial assessing efficacy in treating acutely ill patients. Schizophr Bull. 2013;39 (Suppl 1):S105. 13. Landreth G, Jiang Q, Mandrekar S, Heneka M. PPARgamma agonists as therapeutics for the treatment of Alzheimer's disease. Neurotherapeutics. 2008;5(3):481–489. 14. Sato T, Hanyu H, Hirao K, Kanetaka H, Sakurai H, Iwamoto T. Efficacy of PPAR-γ agonist pioglitazone in mild Alzheimer disease. Neurobiol Aging. 2011;32(9):1626–1633. 15. Nicolakakis N, Hamel E. The Nuclear Receptor PPARgamma as a Therapeutic Target for Cerebrovascular and Brain Dysfunction in Alzheimer's Disease. Front Aging Neurosci. 2010;2. pii: 21. 16. Insel TR. The NIMH Research Domain Criteria (RDoC) Project: precision medicine for psychiatry. Am J Psychiatry. 2014;171(4):395–397. doi: 10.1176/appi.ajp.2014. 17. Arrowsmith J. Trial watch: Phase II failures: 2008-2010. Nat Rev Drug Discov. 2011;10(5):328–329. 18. Arrowsmith J. Trial watch: Phase III and submission failures: 2007-2010. Nat Rev Drug Discov. 2011;10(2):87. 19. Cohen AF. Developing drug prototypes: pharmacology replaces safety and tolerability? Nat Rev Drug Discov. 2010;9(11):856–865. 20. Cross J, Lee H, Westelinck A, Nelson J, Grudzinskas C, Peck C. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999. Pharmacoepidemiol Drug Saf. 2002;11(6):439–446. 21. Hoever P, de Haas S, Winkler J, et al. Orexin receptor antagonism, a new sleep-promoting paradigm: an ascending single-dose study with almorexant. Clin Pharmacol Ther. 2010;87(5):593–600. 22. Klumpers LE, Roy C, Ferron G, et al. Surinabant, a selective CB1 antagonist, inhibits THC-induced central nervous system and heart rate effects in humans. Br J Clin Pharmacol. 2013;76:65–77. 23. Ferrona G, Klumpers L, Van Gerven J, Roy C. PK and PK/PD modeling of CB1 blocker antagonism of THC induced CNS and Heart Rate effects.

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