Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: Rationale, design, and methods

Child and Adolescent Psychiatry and Mental Health

Volumn 7, Issue 1, 2013, Pages

  Reeves, Gloria M ^b   Keeton, Courtney ^a   Correll, Christoph U ^d   Johnson, Jacqueline L ^c   Hamer, Robert M ^c   Sikich, Linmarie ^c   Hazzard, Lindsey ^c   Alderman, Cheryl ^c   Scheer, Abigail ^c   Mabe, Micah ^c   Kapoor, Sandeep ^d   Sheridan, Eva ^d   Borner, Irmgard ^d   Bussell, Kristin ^b   Pirmohamed, Sara ^b   Bethea, Terrence C ^c   Chekuri, Raja ^d   Gottfried, Rhoda ^a   Reinblatt, Shauna P ^a   Santana, Erin ^a   Riddle, Mark A ^a   more..

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^d ZUCKER HILLSIDE HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARIPIPRAZOLE; ASENAPINE; ILOPERIDONE; LURASIDONE; METFORMIN; OLANZAPINE; PALIPERIDONE; PERPHENAZINE; QUETIAPINE; RISPERIDONE; ZIPRASIDONE;

ADOLESCENT; ADULT; ADVERSE OUTCOME; ARTICLE; AUTISM; BIPOLAR DISORDER; BODY FAT; BODY MASS; CHILD; CHILD CARE; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; HUMAN; INSULIN RESISTANCE; INSULIN SENSITIVITY; IRRITABILITY; LIFESTYLE; LIFESTYLE MODIFICATION; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MANIA; MEDICATION COMPLIANCE; MENTAL DISEASE; METABOLIC PARAMETERS; OBESITY; OPEN STUDY; PATIENT EDUCATION; PRIORITY JOURNAL; PSYCHOPHARMACOTHERAPY; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; SCHIZOPHRENIA; SCHOOL CHILD; SIDE EFFECT; TREATMENT WITHDRAWAL; WEIGHT GAIN;

EID: 84881466881     PISSN: None     EISSN: 17532000     Source Type: Journal    
DOI: 10.1186/1753-2000-7-31     Document Type: Article

References (54)

1. Correll CU, Manu P, Olshanskiy V, Napolitano B, Kane JM, Malhotra AK. Cardiometabolic risk of second generation antipsychotics during first-time use in children and adolescents. JAMA 2009, 302:1763-1771.
2. Panagiotopoulos C, Ronsley R, Elbe D, Davidson J, Smith DH. First do no harm: promoting an evidence-based approach to atypical antipsychotic use in children and adolescents. J Can Acad Child Adolesc Psychiatry 2010, 19:124-137. 2868560, 20467549.
3. De Hert M, Detraux J, van Winkel R, Yu W, Correll CU. Metabolic and cardiovascular adverse effects associated with antipsychotic drugs. Nat Rev Endocrinol 2011, 8:114-126. 10.1038/nrendo.2011.156, 22009159.
4. Kuehn BM. Questionable antipsychotic prescribing remains common, despite serious risks. JAMA 2010, 303:1582-1584. 10.1001/jama.2010.453, 20424239.
5. Correll CU, Lencz T, Malhotra AK. Antipsychotic drugs and obesity. Trends Mol Med 2011, 17:97-107. 10.1016/j.molmed.2010.10.010, 3053585, 21185230.
6. Kumra S, Oberstar JV, Sikich L, Findling RL, McClellan JM, Vinogradov S, Schulz SC. Efficacy and tolerability of second-generation antipsychotics in children and adolescents with schizophrenia. SchizophrBull 2008, 34:60-71.
7. Sikich L, Hamer RM, Bashford RA, Scheitman BB, Lieberman JA. A pilot study of risperidone, olanzapine, and haloperidol in psychotic youth: a double-blind, randomized, 8-week trial. Neuropsychopharmacology 2004, 29:133-145. 10.1038/sj.npp.1300327, 14583740.
8. Maayan L, Correll CU. Weight gain and metabolic risks associated with antipsychotic medications in children and adolescents. J Child Adolesc Psychopharmacol 2011, 21:517-535. 10.1089/cap.2011.0015, 22166172.
9. Maayan L, Correll CU. Management of antipsychotic-related weight gain. Expert Rev Neurother 2010, 10:1175-1200. 10.1586/ern.10.85, 3501406, 20586697.
10. Correll CU, Kratochvil CJ, March JS. Developments in pediatric psychopharmacology: focus on stimulants, antidepressants and antipsychotics. J Clin Psychiatry 2011, 72:655-670. 10.4088/JCP.11r07064, 21658348.
11. Mukundan A, Faulkner G, Cohn T, Remington G. Antipsychotic switching for people with schizophrenia who have neuroleptic-induced weight or metabolic problems. Cochrane Database Syst Rev 2010, 12:CD006629.
12. Maayan L, Vakhrusheva J, Correll CU. Effectiveness of medications used to attenuate antipsychotic-related weight gain and metabolic abnormalities: a systematic review and meta-analysis. Neuropsychopharmacology 2010, 35:1520-1530. 10.1038/npp.2010.21, 3055458,3055458, 20336059.
13. Caemmerer J, Correll CU, Maayan L. Acute and maintenance effects of non-pharmacologic interventions for antipsychotic associated weight gain and metabolic abnormalities: a meta-analytic comparison of randomized controlled trials. Schizophr Res 2012, 140:159-168. 10.1016/j.schres.2012.03.017, 22763424.
14. Newcomer JW, Campos JA, Marcus RN, Breder C, Berman RM, Kerselaers W, L'italien GJ, Nys M, Carson WH, McQuade RD. A multicenter, randomized, double-blind study of the effects of aripiprazole in overweight subjects with schizophrenia or schizoaffective disorder switched from olanzapine. J Clin Psychiatry 2008, 69:1046-1056. 10.4088/JCP.v69n0702, 18605811.
15. Wu RR, Zhao JP, Guo XF, He YQ, Fang MS, Guo WB, Chen JD, Li LH. Metformin addition attenuates olanzapine-induced weight gain in drug-naive first-episode schizophrenia patients: a double-blind, placebo-controlled study. Am J Psychiatry 2008, 165:352-358. 10.1176/appi.ajp.2007.07010079, 18245179.
16. Stroup TS, McEvoy JP, Ring KD, Hamer RH, LaVange LM, Swartz MS, Rosenheck RA, Perkins DO, Nussbaum AM, Lieberman JA. Schizophrenia trials network A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk: comparison of antipsychotics for metabolic problems (CAMP). Am J Psychiatry 2011, 168:947-956. 10.1176/appi.ajp.2011.10111609, 21768610, Schizophrenia trials network.
17. Must A, Jacques PF, Dallal GE, Bajema CJ, Dietz WH. Long-term morbidity and mortality of overweight adolescents - a follow-up of the Harvard growth study of 1922 to 1935. N Engl J Med 1992, 327:1350-1355. 10.1056/NEJM199211053271904, 1406836.
18. Baker JL, Olsen LW, Sørensen TI. Childhood body-mass index and the risk of coronary heart disease in adulthood. N Engl J Med 2007, 357:2329-2337. 10.1056/NEJMoa072515, 3062903, 18057335.
19. Hannon TS, Rao G, Arslanian SA. Childhood obesity and type 2 diabetes mellitus. Pediatrics 2005, 116:473-480. 10.1542/peds.2004-2536, 16061606.
20. Sinha R, Fisch G, Teague B, Tamborlane WV, Banyas B, Allen K, Savoye M, Rieger V, Taksali S, Barbetta G, Sherwin RS, Caprio S. Prevalence of impaired glucose tolerance among children and adolescents with marked obesity. N Engl J Med 2002, 346:802-810. 10.1056/NEJMoa012578, 11893791.
21. Serdula MK, Ivery D, Coates RJ, Freedman DS, Williamson DF, Byers T. Do obese children become obese adults? a review of the literature. Prev Med 1993, 22:167-177. 10.1006/pmed.1993.1014, 8483856.
22. Power C, Lake JK, Cole TJ. Body mass index and height from childhood to adulthood in the 1958 British born cohort. Am J Clin Nutr 1997, 66:1094-1101.
23. Guo SS, Chumlea WC. Tracking of body mass index in children in relation to overweight in adulthood. Am J Clin Nutr 1999, 70:145S-148S.
24. Freedman DS, Khan LK, Dietz WH, Srinivasan SR, Berenson GS. Relationship of childhood obesity to coronary heart disease risk factors in adulthood: the Bogalusa heart study. Pediatrics 2001, 108:712-718. 10.1542/peds.108.3.712, 11533341.
25. ADA/APA Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care 2004, 27:596-6001. ADA/APA.
26. Correll CU, Carlson HE. Endocrine and metabolic adverse effects of psychotropic medications in children and adolescents. J Am Acad Child Adolesc Psychiatry 2006, 45:771-791. 10.1097/01.chi.0000220851.94392.30, 16832314.
27. Correll CU. Antipsychotic use in children and adolescents: minimizing adverse effects to maximize outcomes. J Am Acad Child Adolesc Psychiatry 2008, 47:9-20. 10.1097/chi.0b013e31815b5cb1, 18174821.
28. Allison DB, Loebel AD, Lombardo I, Romano SJ, Siu CO. Understanding the relationship between baseline BMI and subsequent weight change in antipsychotic trials: effect modification or regression to the mean?. Psychiatry Res 2009, 170:172-176. 10.1016/j.psychres.2008.10.007, 19897253.
29. Sikich L, Frazier JA, McClellan J, Findling RL, Vitiello B, Ritz L, Ambler D, Puglia M, Maloney AE, Michael E, De Jong S, Slifka K, Noyes N, Hlastala S, Pierson L, McNamara NK, Delporto-Bedoya D, Anderson R, Hamer RM, Lieberman JA. Double-blind comparison of first- and second-generation antipsychotics in early-onset schizophrenia and schizo-affective disorder: findings from the treatment of early-onset schizophrenia spectrum disorders (TEOSS) study. Am J Psychiatry 2008, 165:1420-1431. 10.1176/appi.ajp.2008.08050756, 18794207.
30. Molling PA, Lockner AW, Sauls RJ, Eisenberg L. Committed delinquent boys: the impact of perphenazine and of placebo. Arch Gen Psychiatry 1962, 7:70-76. 10.1001/archpsyc.1962.01720010072009, 14475233.
31. Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK. Clinical antipsychotic trials of intervention effectiveness (CATIE) investigators Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005, 353(12):1209-1223. 10.1056/NEJMoa051688, 16172203, Clinical antipsychotic trials of intervention effectiveness (CATIE) investigators.
32. Strom BL, Eng SM, Faich G, Reynolds RF, D'Agostino RB, Ruskin J, Kane JM. Comparative mortality associated with ziprasidone and olanzapine in real-world use among 18,154 patients with schizophrenia: the ziprasidone observational study of cardiac outcomes (ZODIAC). Am J Psychiatry 2011, 168:193-201. 10.1176/appi.ajp.2010.08040484, 21041245.
33. Whitlock EP, O'Connor EA, Williams SB, Beil TL, Lutz KW. Effectiveness of weight management interventions in children: a targeted systematic review for the USPSTF. Pediatrics 2010, 125:e396-e418. 10.1542/peds.2009-1955, 20083531.
34. Van Mil EG, Westerterp KR, Kester AD, Delemarre-Van De Waal HA, Gerver WJ, Saris WH. The effect of sibutramine on energy expenditure and body composition in obese adolscents. J Clin Endocrinol Metab 2007, 92:1409-1414. 10.1210/jc.2006-0264, 17264187.
35. Qureshi ZP, Seoane-Vazquez E, Rodriguez-Monguio R, Stevenson KB, Szeinbach SL. Market withdrawal of new molecular entitites approved in the United States from 1980 to 2009. Pharmacoepidemiol Drug Saf 2011, 20:772-777. 10.1002/pds.2155, 21574210.
36. Guerciolini R. Mode of action of orlistat. Int J Obes Relat Metab Disord 1997, 21S:12-23.
37. Padwal RS, Majumdar SR. Drug treatments for obesity: orlistat, sibutramine, and rimonabant. Lancet 2007, 369:71-77. 10.1016/S0140-6736(07)60033-6, 17208644.
38. Rogovik AL, Chanoine JP, Goldman RD. Pharmacotherapy and weight-loss supplements for treatment of paediatric obesity. Drugs 2010, 70:335-346.
39. Ferraro D, Di Trapani G. Topiramate in the prevention of pediatric migraine: literature review. J Headache Pain 2008, 9:147-150. 10.1007/s10194-008-0030-1, 2386848,2386848, 18385933.
40. Ellinger LK, Ipema HJ, Stachnik JM. Efficacy of metformin and topiramate in prevention and treatment of second-generation antipsychotic-induced weight gain. Ann Pharmacother 2010, 44:668-679. 10.1345/aph.1M550, 20233913.
41. Kim E, Liu NC, Yu IC, Lin HY, Lee YF, Sparks JD, Chen LM, Chang C. Metformin inhibits nuclear receptor TR4-mediated hepatic stearoyl-CoA desaturase 1 gene expression with altered insulin sensitivity. Diabetes 2011, 60:1493-1503. 10.2337/db10-0393, 3292323, 21478464.
42. Wald AB, Uli NK. Pharmacotherapy in pediatric obesity: current agents and future directions. Rev Endocr Metab Disord 2009, 10:205-214. 10.1007/s11154-009-9111-y, 19688265.
43. Brufani C, Fintini D, Nobili V, Patera PI, Cappa M, Brufani M. Use of metformin in pediatric age. Pediatr Diabetes 2011, 12:580-586.
44. Lee YJ, Jeong JH. A systematic review of metformin to limit weight-gain with atypical antipsychotics. J Clin Pharm Ther 2011, 36:537-545. 10.1111/j.1365-2710.2011.01255.x, 21418264.
45. Björkhem-Bergman L, Asplund AB, Lindh JD. Metformin for weight reduction in non-diabetic patients on antipsychotic drugs: a systematic review and meta-analysis. J Psychopharmacol 2011, 25:299-305. 10.1177/0269881109353461, 20080925.
46. Arman S, Sadramely MR, Nadi M, Koleini N. A randomized, double-blind, placebo-controlled trial of metformin treatment for weight gain associated with initiation of risperidone in children and adolescents. Saudi Med J 2008, 29:1130-1134.
47. Klein DJ, Cottingham EM, Sorter M, Barton BA, Morrison JA. A randomized, double-blind, placebo-controlled trial of metformin treatment of weight gain associated with initiation of atypical antipsychotic therapy in children and adolescents. Am J Psychiatry 2006, 163:2072-2079. 10.1176/appi.ajp.163.12.2072, 17151157.
48. Dixon LB, Dickerson F, Bellack AS, Bennett M, Dickinson D, Goldberg RW, Lehman A, Tenhula WN, Calmes C, Pasillas RM, Peer J, Kreyenbuhl J. Schizophrenia Patient Outcomes Research Team (PORT) The 2009 schizophrenia PORT psychosocial treatment recommendations and summary statements. Schizophr Bull 2010, 36:48-70. 10.1093/schbul/sbp115, 2800143, 19955389, Schizophrenia Patient Outcomes Research Team (PORT).
49. Cook S, Weitzman M, Auinger P, Nguyen M, Dietz WH. Prevalence of a metabolic syndrome phenotype in adolescents: findings from the third national health and nutrition examination survey, 1988-1994. Arch Pediatr Adolesc Med 2003, 157:821-827. 10.1001/archpedi.157.8.821, 12912790.
50. Leibenluft E, Charney DS, Towbin KE, Bhangoo RK, Pine DS. Defining clinical phenotypes of juvenile mania. Am J Psychiatry 2003, 160:430-437. 10.1176/appi.ajp.160.3.430, 12611821.
51. Correll CU. From receptor pharmacology to improved outcomes: individualizing the selection, dosing, and switching of antipsychotics. Eur Psychiatry 2010, 25(2):S12-S21.
52. Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab 2000, 85:2402-2410. 10.1210/jc.85.7.2402, 10902785.
53. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985, 28:412-419. 10.1007/BF00280883, 3899825.
54. Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care 1999, 22:1462-1470. 10.2337/diacare.22.9.1462, 10480510.