Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis

Clinical Therapeutics

Volumn 38, Issue 1, 2016, Pages 4-15

  Chapel, Sunny ^a   Chiu, Yu Yuan ^b   Hsu, Jay ^b   Cucchiaro, Josephine ^b   Loebel, Antony ^b  

^a ANN ARBOR PHARMACOMETRICS GROUP   (United States)

^b DAINIPPON SUMITOMO PHARMA CO LTD   (Japan)

Author keywords

atypical antipsychotic; bipolar disorder; depression; dose response; lurasidone; statistical model

Indexed keywords

LITHIUM; LURASIDONE; PLACEBO; VALPROIC ACID; LITHIUM DERIVATIVE; NEUROLEPTIC AGENT; TRANQUILIZER;

ADJUVANT THERAPY; ADULT; ARTICLE; BIPOLAR DEPRESSION; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFECT; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MONTGOMERY ASBERG DEPRESSION RATING SCALE; PLACEBO EFFECT; POPULATION RESEARCH; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIMULATION; STATISTICAL MODEL; BIPOLAR DISORDER; COMBINATION DRUG THERAPY; COMPUTER SIMULATION; DEPRESSION; DOUBLE BLIND PROCEDURE; MIDDLE AGED; PSYCHOLOGICAL RATING SCALE; RANDOMIZED CONTROLLED TRIAL; THEORETICAL MODEL;

ADULT; ANTIMANIC AGENTS; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; COMPUTER SIMULATION; DEPRESSIVE DISORDER; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; LITHIUM COMPOUNDS; LURASIDONE HYDROCHLORIDE; MALE; MIDDLE AGED; MODELS, THEORETICAL; PLACEBO EFFECT; PSYCHIATRIC STATUS RATING SCALES; VALPROIC ACID;

EID: 84954367500     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2015.11.013     Document Type: Article

References (26)

1. American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders Fifth Edition 2013 American Psychiatric Assocation Arlington, VA
2. L.L. Judd, H.S. Akiskal, P.J. Schettler, and et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder Arch Gen Psychiatry 59 2002 530 537
3. L.L. Judd, H.S. Akiskal, P.J. Schettler, and et al. A prospective investigation of the natural history of the long-term weekly symptomatic status of bipolar II disorder Arch Gen Psychiatry 60 2003 261 269
4. R.W. Kupka, L.L. Altshuler, W.A. Nolen, and et al. Three times more days depressed than manic or hypomanic in both bipolar I and bipolar II disorder Bipolar Disord 9 2007 531 535
5. J.R. Calabrese, R.M. Hirschfeld, M.A. Frye, and M.L. Reed Impact of depressive symptoms compared with manic symptoms in bipolar disorder: results of a U.S. community-based sample J Clin Psychiatry 65 2004 1499 1504
6. N. Huxley, and R.J. Baldessarini Disability and its treatment in bipolar disorder patients Bipolar Disord 9 2007 183 196
7. L.L. Judd, H.S. Akiskal, P.J. Schettler, and et al. Psychosocial disability in the course of bipolar I and II disorders: a prospective, comparative, longitudinal study Arch Gen Psychiatry 62 2005 1322 1330
8. R.C. Kessler, H.S. Akiskal, M. Ames, and et al. Prevalence and effects of mood disorders on work performance in a nationally representative sample of U.S. workers Am J Psychiatry 163 2006 1561 1568
9. S.C. Dilsaver, Y.W. Chen, A.C. Swann, and et al. Suicidality, panic disorder and psychosis in bipolar depression, depressive-mania and pure-mania Psychiatry Res 73 1997 47 56
10. G.S. Leverich, L.L. Altshuler, M.A. Frye, and et al. Factors associated with suicide attempts in 648 patients with bipolar disorder in the Stanley Foundation Bipolar Network J Clin Psychiatry 64 2003 506 515
11. 1A receptor activity J Pharmacol Exp Ther 334 2010 171 181
12. A. Loebel, J. Cucchiaro, R. Silva, and et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study Am J Psychiatry 171 2014 160 168
13. A. Loebel, J. Cucchiaro, R. Silva, and et al. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study Am J Psychiatry 171 2014 169 177
14. I. Lipkovich, D. Baron, J. Houston, and et al. Flexible-dose clinical trials: predictors and outcomes of antipsychotic dose adjustments J Clin Psychopharmacol 25 2005 381 386
15. L.E. Friberg, R. de Greef, T. Kerbusch, and M.O. Karlsson Modeling and simulation of the time course of asenapine exposure response and dropout patterns in acute schizophrenia Clin Pharmacol Ther 86 2009 84 91
16. I. Lipkovich, D.H. Adams, C. Mallinckrodt, and et al. Evaluating dose response from flexible dose clinical trials BMC Psychiatry 8 2008 3
17. H.C. Kimko, S.S.B. Reele, N.H.G. Holford, and C.C. Peck Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumarate) by simulation with a population pharmacokinetic and pharmacodynamic model Clin Pharmacol Ther 68 2000 568 577
18. V. Pilla Reddy, M. Kozielska, M. Johnson, and et al. Population pharmacokinetic-pharmacodynamic modeling of haloperidol in patients with schizophrenia using positive and negative syndrome rating scale J Clin Psychopharmacol 33 2013 731 739
19. V. Pilla Reddy, M. Kozielska, A.A. Suleiman, and et al. Pharmacokinetic-pharmacodynamic modelling of antipsychotic drugs in patients with schizophrenia: part II: the use of subscales of the PANSS score Schizophr Res 146 2013 153 161
20. D.W. Shang, L.J. Li, X.P. Wang, and et al. Population pharmacokinetic/pharmacodynamic model of clozapine for characterizing the relationship between accumulated exposure and PANSS scores in patients with schizophrenia Ther Drug Monit 36 2014 378 386
21. S.A. Montgomery, and M. Åsberg A new depression scale designed to be sensitive to change Br J Psychiatry 134 1979 382 389
22. R.P. Snaith, F.M. Harrop, D.A. Newby, and C. Teale Grade scores of the Montgomery-Asberg Depression and the Clinical Anxiety Scales Br J Psychiatry 148 1986 599 601
23. Y. Yano, S.L. Beal, and L.B. Sheiner Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check J Pharmacokinet Pharmacodyn 28 2001 171 192
24. G. Duru, and B. Fantino The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach Curr Med Res Opin 24 2008 1329 1335
25. A. Russu, E. Marostica, G. De Nicolao, and et al. Joint modeling of efficacy, dropout, and tolerability in flexible-dose trials: a case study in depression Clin Pharmacol Ther 91 2012 863 871
26. A. Khan, S.R. Khan, G. Walens, and et al. Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the food and drug administration summary basis of approval reports Neuropsychopharmacology 28 2003 552 557