1/2-MC4R genotyp och pediatrisk antipsykotisk läkemedelsinducerad viktökning
6 januari 2016 uppdaterad av: Anil K. Malhotra, Northwell Health
Vi kommer att genomföra en 12-veckors, randomiserad öppen studie, där vi jämför antipsykotisk behandling med vanlig vård (UC) (aripiprazol, quetiapin, risperidon) med ziprasidon (ZIP) hos barn och ungdomar i åldern 13-18 år.
Patienter kommer att ha 10 dagar eller mindre livstidsexponering för antipsykotiska läkemedel och vara i kliniskt behov av antipsykotisk behandling för en psykiatrisk sjukdom hos barn med FDA-indikation för antipsykotisk användning, d.v.s. bipolär mani, schizofrenispektrumstörningar och irritabilitet förknippad med autistisk störning.
Dessutom kommer vi även att inkludera ungdomar som uppfyller forskningsdiagnostiska kriterier för svår humörstörning (SMD).
Randomisering kommer att stratifieras av hög kontra låg genetisk risk för antipsykotiska-inducerad viktökning baserat på MC4R-genotyp och det primära resultatet kommer att vara viktförändring från baslinje till endpoint mellan ZIP och UC antipsykotisk behandling i var och en av de två genotypgrupperna.
Som beskrivs i detalj nedan kommer även andra metabola och hjärtsäkerhetsparametrar att mätas och jämföras över behandlingar i var och en av genotypgrupperna.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
14
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New York
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Glen Oaks, New York, Förenta staterna, 11004
- Zucker Hillside Hospital, Psychiatry Research
-
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
13 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inklusionskriterier:
- ålder 13-18 år
- Engelsktalande
- DSM-diagnoser som har en FDA-indikation för SGA-användning för minst ett medel i respektive pediatrisk eller vuxen åldersgrupp. Närmare bestämt primär DSM-IV-diagnos av schizofrenispektrumstörningar i tidiga debut; bipolär I-störningsmani (och BP-NOS); irritabilitet förknippad med autismspektrumstörning, samt svår humörstörning (SMD) enligt Leibenluft et al. (2011) med en ABC-irritabilitetspoäng på >/=18 Sexuellt aktiva tjejer måste gå med på att använda två effektiva former av preventivmedel eller vara abstinenta
- Deltagaren har en primärvårdare som har känt barnet väl i minst 6 månader före studiestart Primärvårdaren har möjlighet att delta i studiebesök
- Barnets förmåga att delta i alla aspekter av protokollet enligt utredarens kliniska bedömning.
Exklusions kriterier:
- Större neurologiska eller medicinska sjukdomar som påverkar vikten (t.ex. instabil sköldkörtelsjukdom) kräver en förbjuden systemisk medicinering (t.ex. diabetes mellitus [insulin], kronisk njursvikt [steroider); Fasteglukos > 125 mg/dL vid 2 tillfällen under screening
- Alla mediciner (andra än för närvarande ordinerade psykotropa mediciner) som väsentligt skulle förändra vikten
- Antidepressiva medel inte tillåtna på minst 2 veckor hos patienter med BP-I eller BP-NOS
- DSM-IV diagnos av anorexi eller bulimia nervosa
- DSM-IV diagnos av substansberoende (annat än tobaksberoende) under den senaste månaden
- Inledande urintoxikologisk skärm och uppföljningsskärm indikerar pågående användning av olaglig substans
- Överkänslighet mot ZIP eller UC antipsykotika
- Gravid, ammar eller ovillig att följa preventivmedelskrav
- Screening eller baslinje QTc > 450 msek
- IQ < 55
- Betydande risk för fara för dig själv eller för andra
- Pågående eller tidigare oupptäckt övergrepp mot barn som kräver ny avdelning för socialtjänstinsatser.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Ziprasidon
(20-160mg/d, bud) i 12 veckor
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slumpmässig tilldelning till ZIP (20-160mg/d, buddosering)
Andra namn:
|
|
Aktiv komparator: Aripiprazol, quetiapin, risperidon
Aripiprazol (2-30mg/d), Quetiapin (25-800mg/d) eller risperidon (0,1-8mg/d) i 12 veckor
|
slumpmässig tilldelning till Usual Care antipsykotiskt UC antipsykotiskt medel (aripiprazol 2-30mg/d, quetiapin 25-800mg/d eller risperidon 0,1-8mg/d)
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Viktförändring
Tidsram: baslinje till vecka 12
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baslinje till vecka 12
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Viktförändring i procent jämfört med baslinjevikt
Tidsram: baslinje till vecka 12
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baslinje till vecka 12
|
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BMI Z-poäng
Tidsram: baslinje till vecka 12
|
baslinje till vecka 12
|
|
BMI-percentil
Tidsram: baslinje till vecka 12
|
baslinje till vecka 12
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.
- 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 Jul;85(7):2402-10. doi: 10.1210/jcem.85.7.6661.
- Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.
- 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 Jul;28(7):412-9. doi: 10.1007/BF00280883.
- Price AL, Patterson NJ, Plenge RM, Weinblatt ME, Shadick NA, Reich D. Principal components analysis corrects for stratification in genome-wide association studies. Nat Genet. 2006 Aug;38(8):904-9. doi: 10.1038/ng1847. Epub 2006 Jul 23.
- Allison DB, Mentore JL, Heo M, Chandler LP, Cappelleri JC, Infante MC, Weiden PJ. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999 Nov;156(11):1686-96. doi: 10.1176/ajp.156.11.1686.
- 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 Aug;157(8):821-7. doi: 10.1001/archpedi.157.8.821.
- Marshall WA, Tanner JM. Variations in pattern of pubertal changes in girls. Arch Dis Child. 1969 Jun;44(235):291-303. doi: 10.1136/adc.44.235.291. No abstract available.
- Simpson GM, Angus JW. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl. 1970;212:11-9. doi: 10.1111/j.1600-0447.1970.tb02066.x. No abstract available.
- Leibenluft E. Severe mood dysregulation, irritability, and the diagnostic boundaries of bipolar disorder in youths. Am J Psychiatry. 2011 Feb;168(2):129-42. doi: 10.1176/appi.ajp.2010.10050766. Epub 2010 Dec 1.
- Axelson D, Birmaher B, Strober M, Gill MK, Valeri S, Chiappetta L, Ryan N, Leonard H, Hunt J, Iyengar S, Bridge J, Keller M. Phenomenology of children and adolescents with bipolar spectrum disorders. Arch Gen Psychiatry. 2006 Oct;63(10):1139-48. doi: 10.1001/archpsyc.63.10.1139.
- DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
- DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x.
- Tanner JM, Whitehouse RH. Clinical longitudinal standards for height, weight, height velocity, weight velocity, and stages of puberty. Arch Dis Child. 1976 Mar;51(3):170-9. doi: 10.1136/adc.51.3.170.
- Basile VS, Masellis M, McIntyre RS, Meltzer HY, Lieberman JA, Kennedy JL. Genetic dissection of atypical antipsychotic-induced weight gain: novel preliminary data on the pharmacogenetic puzzle. J Clin Psychiatry. 2001;62 Suppl 23:45-66.
- Isolan L, Pheula G, Salum GA Jr, Oswald S, Rohde LA, Manfro GG. An open-label trial of escitalopram in children and adolescents with social anxiety disorder. J Child Adolesc Psychopharmacol. 2007 Dec;17(6):751-60. doi: 10.1089/cap.2007.0007.
- 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 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19. Erratum In: N Engl J Med. 2010 Sep 9;363(11):1092-3.
- Ridker PM. C-reactive protein, inflammation, and cardiovascular disease: clinical update. Tex Heart Inst J. 2005;32(3):384-6. No abstract available.
- Beckers S, Zegers D, de Freitas F, Mertens IL, Van Gaal LF, Van Hul W. Association study of MC4R with complex obesity and replication of the rs17782313 association signal. Mol Genet Metab. 2011 May;103(1):71-5. doi: 10.1016/j.ymgme.2011.01.007. Epub 2011 Jan 22.
- Birmaher B, Axelson D, Goldstein B, Strober M, Gill MK, Hunt J, Houck P, Ha W, Iyengar S, Kim E, Yen S, Hower H, Esposito-Smythers C, Goldstein T, Ryan N, Keller M. Four-year longitudinal course of children and adolescents with bipolar spectrum disorders: the Course and Outcome of Bipolar Youth (COBY) study. Am J Psychiatry. 2009 Jul;166(7):795-804. doi: 10.1176/appi.ajp.2009.08101569. Epub 2009 May 15.
- Birmaher B, Axelson D, Strober M, Gill MK, Valeri S, Chiappetta L, Ryan N, Leonard H, Hunt J, Iyengar S, Keller M. Clinical course of children and adolescents with bipolar spectrum disorders. Arch Gen Psychiatry. 2006 Feb;63(2):175-83. doi: 10.1001/archpsyc.63.2.175.
- Branson R, Potoczna N, Kral JG, Lentes KU, Hoehe MR, Horber FF. Binge eating as a major phenotype of melanocortin 4 receptor gene mutations. N Engl J Med. 2003 Mar 20;348(12):1096-103. doi: 10.1056/NEJMoa021971.
- Brotons C, Ribera A, Perich RM, Abrodos D, Magana P, Pablo S, Terradas D, Fernandez F, Permanyer G. Worldwide distribution of blood lipids and lipoproteins in childhood and adolescence: a review study. Atherosclerosis. 1998 Jul;139(1):1-9. doi: 10.1016/s0021-9150(98)00056-2.
- Chambers JC, Elliott P, Zabaneh D, Zhang W, Li Y, Froguel P, Balding D, Scott J, Kooner JS. Common genetic variation near MC4R is associated with waist circumference and insulin resistance. Nat Genet. 2008 Jun;40(6):716-8. doi: 10.1038/ng.156. Epub 2008 May 4.
- Chen AS, Metzger JM, Trumbauer ME, Guan XM, Yu H, Frazier EG, Marsh DJ, Forrest MJ, Gopal-Truter S, Fisher J, Camacho RE, Strack AM, Mellin TN, MacIntyre DE, Chen HY, Van der Ploeg LH. Role of the melanocortin-4 receptor in metabolic rate and food intake in mice. Transgenic Res. 2000 Apr;9(2):145-54. doi: 10.1023/a:1008983615045.
- Comer JS, Mojtabai R, Olfson M. National trends in the antipsychotic treatment of psychiatric outpatients with anxiety disorders. Am J Psychiatry. 2011 Oct;168(10):1057-65. doi: 10.1176/appi.ajp.2011.11010087. Epub 2011 Jul 28.
- Correll CU, Kratochvil CJ, March JS. Developments in pediatric psychopharmacology: focus on stimulants, antidepressants, and antipsychotics. J Clin Psychiatry. 2011 May;72(5):655-70. doi: 10.4088/JCP.11r07064.
- Correll CU, Lencz T, Malhotra AK. Antipsychotic drugs and obesity. Trends Mol Med. 2011 Feb;17(2):97-107. doi: 10.1016/j.molmed.2010.10.010. Epub 2010 Dec 22.
- Correll CU, Malhotra AK. Pharmacogenetics of antipsychotic-induced weight gain. Psychopharmacology (Berl). 2004 Aug;174(4):477-89. doi: 10.1007/s00213-004-1949-9. Epub 2004 Jul 8.
- Correll CU, Manu P, Olshanskiy V, Napolitano B, Kane JM, Malhotra AK. Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents. JAMA. 2009 Oct 28;302(16):1765-73. doi: 10.1001/jama.2009.1549. Erratum In: JAMA. 2009 Dec 2;302(21):2322.
- Crystal S, Olfson M, Huang C, Pincus H, Gerhard T. Broadened use of atypical antipsychotics: safety, effectiveness, and policy challenges. Health Aff (Millwood). 2009 Sep-Oct;28(5):w770-81. doi: 10.1377/hlthaff.28.5.w770. Epub 2009 Jul 21.
- 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 Oct 18;8(2):114-26. doi: 10.1038/nrendo.2011.156.
- De Hert M, Dobbelaere M, Sheridan EM, Cohen D, Correll CU. Metabolic and endocrine adverse effects of second-generation antipsychotics in children and adolescents: A systematic review of randomized, placebo controlled trials and guidelines for clinical practice. Eur Psychiatry. 2011 Apr;26(3):144-58. doi: 10.1016/j.eurpsy.2010.09.011. Epub 2011 Feb 3.
- DelBello MP, Versavel M, Ice K, Keller D, Miceli J. Tolerability of oral ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder. J Child Adolesc Psychopharmacol. 2008 Oct;18(5):491-9. doi: 10.1089/cap.2008.008.
- DelBello MP, Findling RL, Wang PP, Gundapaneni BP, Versavel M. Efficacy and safety of ziprasidone in pediatric bipolar disorder. Annual NCDEU Meeting, Phoenix, AZ, May 27-30, 2008.
- Dennison BA, Russo TJ, Burdick PA, Jenkins PL. An intervention to reduce television viewing by preschool children. Arch Pediatr Adolesc Med. 2004 Feb;158(2):170-6. doi: 10.1001/archpedi.158.2.170.
- Dickstein DP, Towbin KE, Van Der Veen JW, Rich BA, Brotman MA, Knopf L, Onelio L, Pine DS, Leibenluft E. Randomized double-blind placebo-controlled trial of lithium in youths with severe mood dysregulation. J Child Adolesc Psychopharmacol. 2009 Feb;19(1):61-73. doi: 10.1089/cap.2008.044.
- Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998 Mar;101(3 Pt 2):518-25.
- Findling RL, Cavus I, Pappadopulos E, Bachinsly M, Schwartz J, Vanderburg D. Efficacy and safety of ziprasidone in adolescents with schizophrenia. Presented at the 2nd Bi-annual Meeting of the Schizophrenia International Research Society (SIRS), April 10-14, 2010, Venice, Italy.
- Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, Shea MT, Imber SD, Sotsky SM, Watkins JT. Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of Depression Collaborative Research Program dataset. Arch Gen Psychiatry. 1993 Sep;50(9):739-50. doi: 10.1001/archpsyc.1993.01820210073009.
- Guo SS, Roche AF, Chumlea WC, Gardner JD, Siervogel RM. The predictive value of childhood body mass index values for overweight at age 35 y. Am J Clin Nutr. 1994 Apr;59(4):810-9. doi: 10.1093/ajcn/59.4.810.
- Guy W. ECDEU Assessment Manual for Psychopharmacology, revised, 1976 Vol DHEW Pub. No. (ADM) 76-338. Rockville, MD: National Institute of Mental Health.
- Heard-Costa NL, Zillikens MC, Monda KL, Johansson A, Harris TB, Fu M, Haritunians T, Feitosa MF, Aspelund T, Eiriksdottir G, Garcia M, Launer LJ, Smith AV, Mitchell BD, McArdle PF, Shuldiner AR, Bielinski SJ, Boerwinkle E, Brancati F, Demerath EW, Pankow JS, Arnold AM, Chen YD, Glazer NL, McKnight B, Psaty BM, Rotter JI, Amin N, Campbell H, Gyllensten U, Pattaro C, Pramstaller PP, Rudan I, Struchalin M, Vitart V, Gao X, Kraja A, Province MA, Zhang Q, Atwood LD, Dupuis J, Hirschhorn JN, Jaquish CE, O'Donnell CJ, Vasan RS, White CC, Aulchenko YS, Estrada K, Hofman A, Rivadeneira F, Uitterlinden AG, Witteman JC, Oostra BA, Kaplan RC, Gudnason V, O'Connell JR, Borecki IB, van Duijn CM, Cupples LA, Fox CS, North KE. NRXN3 is a novel locus for waist circumference: a genome-wide association study from the CHARGE Consortium. PLoS Genet. 2009 Jun;5(6):e1000539. doi: 10.1371/journal.pgen.1000539. Epub 2009 Jun 26.
- Henderson DC, Cagliero E, Gray C, Nasrallah RA, Hayden DL, Schoenfeld DA, Goff DC. Clozapine, diabetes mellitus, weight gain, and lipid abnormalities: A five-year naturalistic study. Am J Psychiatry. 2000 Jun;157(6):975-81. doi: 10.1176/appi.ajp.157.6.975.
- Hughes CW, Rintelmann J, Emslie GJ, Lopez M, MacCabe N. A revised anchored version of the BPRS-C for childhood psychiatric disorders. J Child Adolesc Psychopharmacol. 2001 Spring;11(1):77-93. doi: 10.1089/104454601750143500.
- Huszar D, Lynch CA, Fairchild-Huntress V, Dunmore JH, Fang Q, Berkemeier LR, Gu W, Kesterson RA, Boston BA, Cone RD, Smith FJ, Campfield LA, Burn P, Lee F. Targeted disruption of the melanocortin-4 receptor results in obesity in mice. Cell. 1997 Jan 10;88(1):131-41. doi: 10.1016/s0092-8674(00)81865-6.
- Kahn RS, Fleischhacker WW, Boter H, Davidson M, Vergouwe Y, Keet IP, Gheorghe MD, Rybakowski JK, Galderisi S, Libiger J, Hummer M, Dollfus S, Lopez-Ibor JJ, Hranov LG, Gaebel W, Peuskens J, Lindefors N, Riecher-Rossler A, Grobbee DE; EUFEST study group. Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet. 2008 Mar 29;371(9618):1085-97. doi: 10.1016/S0140-6736(08)60486-9.
- Kang SJ, Chiang CW, Palmer CD, Tayo BO, Lettre G, Butler JL, Hackett R, Adeyemo AA, Guiducci C, Berzins I, Nguyen TT, Feng T, Luke A, Shriner D, Ardlie K, Rotimi C, Wilks R, Forrester T, McKenzie CA, Lyon HN, Cooper RS, Zhu X, Hirschhorn JN. Genome-wide association of anthropometric traits in African- and African-derived populations. Hum Mol Genet. 2010 Jul 1;19(13):2725-38. doi: 10.1093/hmg/ddq154. Epub 2010 Apr 16.
- Kiess W, Reich A, Muller G, Meyer K, Galler A, Bennek J, Kratzsch J. Clinical aspects of obesity in childhood and adolescence--diagnosis, treatment and prevention. Int J Obes Relat Metab Disord. 2001 May;25 Suppl 1:S75-9. doi: 10.1038/sj.ijo.0801704.
- Kolotkin RL, Crosby RD, Corey-Lisle PK, Li H, Swanson JM. Performance of a weight-related measure of Quality of Life in a psychiatric sample. Qual Life Res. 2006 May;15(4):587-96. doi: 10.1007/s11136-005-4627-4.
- Kolotkin RL, Zeller M, Modi AC, Samsa GP, Quinlan NP, Yanovski JA, Bell SK, Maahs DM, de Serna DG, Roehrig HR. Assessing weight-related quality of life in adolescents. Obesity (Silver Spring). 2006 Mar;14(3):448-57. doi: 10.1038/oby.2006.59.
- Koponen H, Saari K, Savolainen M, Isohanni M. Weight gain and glucose and lipid metabolism disturbances during antipsychotic medication: a review. Eur Arch Psychiatry Clin Neurosci. 2002 Dec;252(6):294-8. doi: 10.1007/s00406-002-0394-1.
- Leibenluft E, Charney DS, Towbin KE, Bhangoo RK, Pine DS. Defining clinical phenotypes of juvenile mania. Am J Psychiatry. 2003 Mar;160(3):430-7. doi: 10.1176/appi.ajp.160.3.430.
- Lencz T, Lambert C, DeRosse P, Burdick KE, Morgan TV, Kane JM, Kucherlapati R, Malhotra AK. Runs of homozygosity reveal highly penetrant recessive loci in schizophrenia. Proc Natl Acad Sci U S A. 2007 Dec 11;104(50):19942-7. doi: 10.1073/pnas.0710021104. Epub 2007 Dec 5.
- Lencz T, Malhotra AK. Pharmacogenetics of antipsychotic-induced side effects. Dialogues Clin Neurosci. 2009;11(4):405-15. doi: 10.31887/DCNS.2009.11.4/tlencz.
- Lencz T, Morgan TV, Athanasiou M, Dain B, Reed CR, Kane JM, Kucherlapati R, Malhotra AK. Converging evidence for a pseudoautosomal cytokine receptor gene locus in schizophrenia. Mol Psychiatry. 2007 Jun;12(6):572-80. doi: 10.1038/sj.mp.4001983. Epub 2007 Mar 20.
- Liebzeit KA, Markowitz JS, Caley CF. New onset diabetes and atypical antipsychotics. Eur Neuropsychopharmacol. 2001 Feb;11(1):25-32. doi: 10.1016/s0924-977x(00)00127-9.
- Little, R. & Rubin D. 2002. Statistical analysis with missing data. New York, John Wiley & Sons, Inc.
- Loos RJ, Lindgren CM, Li S, Wheeler E, Zhao JH, Prokopenko I, Inouye M, Freathy RM, Attwood AP, Beckmann JS, Berndt SI; Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial; Jacobs KB, Chanock SJ, Hayes RB, Bergmann S, Bennett AJ, Bingham SA, Bochud M, Brown M, Cauchi S, Connell JM, Cooper C, Smith GD, Day I, Dina C, De S, Dermitzakis ET, Doney AS, Elliott KS, Elliott P, Evans DM, Sadaf Farooqi I, Froguel P, Ghori J, Groves CJ, Gwilliam R, Hadley D, Hall AS, Hattersley AT, Hebebrand J, Heid IM; KORA; Lamina C, Gieger C, Illig T, Meitinger T, Wichmann HE, Herrera B, Hinney A, Hunt SE, Jarvelin MR, Johnson T, Jolley JD, Karpe F, Keniry A, Khaw KT, Luben RN, Mangino M, Marchini J, McArdle WL, McGinnis R, Meyre D, Munroe PB, Morris AD, Ness AR, Neville MJ, Nica AC, Ong KK, O'Rahilly S, Owen KR, Palmer CN, Papadakis K, Potter S, Pouta A, Qi L; Nurses' Health Study; Randall JC, Rayner NW, Ring SM, Sandhu MS, Scherag A, Sims MA, Song K, Soranzo N, Speliotes EK; Diabetes Genetics Initiative; Syddall HE, Teichmann SA, Timpson NJ, Tobias JH, Uda M; SardiNIA Study; Vogel CI, Wallace C, Waterworth DM, Weedon MN; Wellcome Trust Case Control Consortium; Willer CJ; FUSION; Wraight, Yuan X, Zeggini E, Hirschhorn JN, Strachan DP, Ouwehand WH, Caulfield MJ, Samani NJ, Frayling TM, Vollenweider P, Waeber G, Mooser V, Deloukas P, McCarthy MI, Wareham NJ, Barroso I, Jacobs KB, Chanock SJ, Hayes RB, Lamina C, Gieger C, Illig T, Meitinger T, Wichmann HE, Kraft P, Hankinson SE, Hunter DJ, Hu FB, Lyon HN, Voight BF, Ridderstrale M, Groop L, Scheet P, Sanna S, Abecasis GR, Albai G, Nagaraja R, Schlessinger D, Jackson AU, Tuomilehto J, Collins FS, Boehnke M, Mohlke KL. Common variants near MC4R are associated with fat mass, weight and risk of obesity. Nat Genet. 2008 Jun;40(6):768-75. doi: 10.1038/ng.140. Epub 2008 May 4.
- Malhotra AK, Correll CU, Chowdhury NI, Muller DJ, Gregersen PK, Lee AT, Tiwari AK, Kane JM, Fleischhacker WW, Kahn RS, Ophoff RA, Meltzer HY, Lencz T, Kennedy JL. Association between common variants near the melanocortin 4 receptor gene and severe antipsychotic drug-induced weight gain. Arch Gen Psychiatry. 2012 Sep;69(9):904-12. doi: 10.1001/archgenpsychiatry.2012.191.
- Malone RP, Delaney MA, Hyman SB, Cater JR. Ziprasidone in adolescents with autism: an open-label pilot study. J Child Adolesc Psychopharmacol. 2007 Dec;17(6):779-90. doi: 10.1089/cap.2006.0126.
- Maayan L, Correll CU. Weight gain and metabolic risks associated with antipsychotic medications in children and adolescents. J Child Adolesc Psychopharmacol. 2011 Dec;21(6):517-35. doi: 10.1089/cap.2011.0015. Epub 2011 Dec 13.
- Mundt JC, Greist JH, Gelenberg AJ, Katzelnick DJ, Jefferson JW, Modell JG. Feasibility and validation of a computer-automated Columbia-Suicide Severity Rating Scale using interactive voice response technology. J Psychiatr Res. 2010 Dec;44(16):1224-8. doi: 10.1016/j.jpsychires.2010.04.025. Epub 2010 Jun 2.
- 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 Nov 5;327(19):1350-5. doi: 10.1056/NEJM199211053271904.
- Okasora K, Takaya R, Tokuda M, Fukunaga Y, Oguni T, Tanaka H, Konishi K, Tamai H. Comparison of bioelectrical impedance analysis and dual energy X-ray absorptiometry for assessment of body composition in children. Pediatr Int. 1999 Apr;41(2):121-5. doi: 10.1046/j.1442-200x.1999.4121048.x.
- Olfson M, Blanco C, Liu L, Moreno C, Laje G. National trends in the outpatient treatment of children and adolescents with antipsychotic drugs. Arch Gen Psychiatry. 2006 Jun;63(6):679-85. doi: 10.1001/archpsyc.63.6.679.
- Olfson M, Crystal S, Huang C, Gerhard T. Trends in antipsychotic drug use by very young, privately insured children. J Am Acad Child Adolesc Psychiatry. 2010 Jan;49(1):13-23. doi: 10.1097/00004583-201001000-00005.
- Pandina GJ, Aman MG, Findling RL. Risperidone in the management of disruptive behavior disorders. J Child Adolesc Psychopharmacol. 2006 Aug;16(4):379-92. doi: 10.1089/cap.2006.16.379.
- Parsons B, Allison DB, Loebel A, Williams K, Giller E, Romano S, Siu C. Weight effects associated with antipsychotics: a comprehensive database analysis. Schizophr Res. 2009 May;110(1-3):103-10. doi: 10.1016/j.schres.2008.09.025. Epub 2009 Mar 24.
- Psychological Corporation (1999): Wechsler Abbreviated Scale of Intelligence (WASI) manual. San-Antonio, Tx.
- Qi L, Kraft P, Hunter DJ, Hu FB. The common obesity variant near MC4R gene is associated with higher intakes of total energy and dietary fat, weight change and diabetes risk in women. Hum Mol Genet. 2008 Nov 15;17(22):3502-8. doi: 10.1093/hmg/ddn242. Epub 2008 Aug 12.
- Raper N, Perloff B, Ingwersen L, Steinfeldt L, Anand J. An overview of USDA's dietary intake data system. Journal of Food Composition and Analysis 2004; 17;545-55.
- Rifai N, Warnick GR, McNamara JR, Belcher JD, Grinstead GF, Frantz ID Jr. Measurement of low-density-lipoprotein cholesterol in serum: a status report. Clin Chem. 1992 Jan;38(1):150-60.
- Robinson DG, Woerner MG, Napolitano B, Patel RC, Sevy SM, Gunduz-Bruce H, Soto-Perello JM, Mendelowitz A, Khadivi A, Miller R, McCormack J, Lorell BS, Lesser ML, Schooler NR, Kane JM. Randomized comparison of olanzapine versus risperidone for the treatment of first-episode schizophrenia: 4-month outcomes. Am J Psychiatry. 2006 Dec;163(12):2096-102. doi: 10.1176/ajp.2006.163.12.2096.
- Rosenfeld JA, Malhotra AK, Lencz T. Novel multi-nucleotide polymorphisms in the human genome characterized by whole genome and exome sequencing. Nucleic Acids Res. 2010 Oct;38(18):6102-11. doi: 10.1093/nar/gkq408. Epub 2010 May 20.
- Safer DJ. A comparison of risperidone-induced weight gain across the age span. J Clin Psychopharmacol. 2004 Aug;24(4):429-36. doi: 10.1097/01.jcp.0000130558.86125.5b.
- Scherag A, Jarick I, Grothe J, Biebermann H, Scherag S, Volckmar AL, Vogel CI, Greene B, Hebebrand J, Hinney A. Investigation of a genome wide association signal for obesity: synthetic association and haplotype analyses at the melanocortin 4 receptor gene locus. PLoS One. 2010 Nov 15;5(11):e13967. doi: 10.1371/journal.pone.0013967.
- 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 Nov;165(11):1420-31. doi: 10.1176/appi.ajp.2008.08050756. Epub 2008 Sep 15. Erratum In: Am J Psychiatry. 2008 Nov;165(11):1495.
- Snitker S, Le KY, Hager E, Caballero B, Black MM. Association of physical activity and body composition with insulin sensitivity in a community sample of adolescents. Arch Pediatr Adolesc Med. 2007 Jul;161(7):677-83. doi: 10.1001/archpedi.161.7.677.
- 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 Feb;168(2):193-201. doi: 10.1176/appi.ajp.2010.08040484. Epub 2010 Nov 1.
- Stutzmann F, Cauchi S, Durand E, Calvacanti-Proenca C, Pigeyre M, Hartikainen AL, Sovio U, Tichet J, Marre M, Weill J, Balkau B, Potoczna N, Laitinen J, Elliott P, Jarvelin MR, Horber F, Meyre D, Froguel P. Common genetic variation near MC4R is associated with eating behaviour patterns in European populations. Int J Obes (Lond). 2009 Mar;33(3):373-8. doi: 10.1038/ijo.2008.279. Epub 2009 Jan 20.
- Tyrrell VJ, Richards G, Hofman P, Gillies GF, Robinson E, Cutfield WS. Foot-to-foot bioelectrical impedance analysis: a valuable tool for the measurement of body composition in children. Int J Obes Relat Metab Disord. 2001 Feb;25(2):273-8. doi: 10.1038/sj.ijo.0801531.
- Tiwari AK, Zai CC, Likhodi O, Lisker A, Singh D, Souza RP, Batra P, Zaidi SH, Chen S, Liu F, Puls I, Meltzer HY, Lieberman JA, Kennedy JL, Muller DJ. A common polymorphism in the cannabinoid receptor 1 (CNR1) gene is associated with antipsychotic-induced weight gain in Schizophrenia. Neuropsychopharmacology. 2010 May;35(6):1315-24. doi: 10.1038/npp.2009.235. Epub 2010 Jan 27.
- Valladares M, Dominguez-Vasquez P, Obregon AM, Weisstaub G, Burrows R, Maiz A, Santos JL. Melanocortin-4 receptor gene variants in Chilean families: association with childhood obesity and eating behavior. Nutr Neurosci. 2010 Apr;13(2):71-8. doi: 10.1179/147683010X12611460763643.
- Vanhala M. Childhood weight and metabolic syndrome in adults. Ann Med. 1999 Aug;31(4):236-9. doi: 10.3109/07853899908995885.
- Waxmonsky J, Pelham WE, Gnagy E, Cummings MR, O'Connor B, Majumdar A, Verley J, Hoffman MT, Massetti GA, Burrows-MacLean L, Fabiano GA, Waschbusch DA, Chacko A, Arnold FW, Walker KS, Garefino AC, Robb JA. The efficacy and tolerability of methylphenidate and behavior modification in children with attention-deficit/hyperactivity disorder and severe mood dysregulation. J Child Adolesc Psychopharmacol. 2008 Dec;18(6):573-88. doi: 10.1089/cap.2008.065.
- Wu L, Xi B, Zhang M, Shen Y, Zhao X, Cheng H, Hou D, Sun D, Ott J, Wang X, Mi J. Associations of six single nucleotide polymorphisms in obesity-related genes with BMI and risk of obesity in Chinese children. Diabetes. 2010 Dec;59(12):3085-9. doi: 10.2337/db10-0273. Epub 2010 Sep 15.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2013
Primärt slutförande (Faktisk)
1 april 2014
Avslutad studie (Faktisk)
1 april 2014
Studieregistreringsdatum
Först inskickad
29 april 2013
Först inskickad som uppfyllde QC-kriterierna
30 april 2013
Första postat (Uppskatta)
1 maj 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Kroppsvikt
- Förändringar i kroppsvikt
- Viktökning
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Antipsykotiska medel
- Lugnande medel
- Psykotropa droger
- Serotoninmedel
- Antidepressiva medel
- Dopaminagonister
- Dopaminmedel
- Serotonin 5-HT1-receptoragonister
- Serotoninreceptoragonister
- Serotonin 5-HT2-receptorantagonister
- Serotoninantagonister
- Dopamin D2-receptorantagonister
- Dopaminantagonister
- Aripiprazol
- Quetiapinfumarat
- Risperidon
- Ziprasidon
Andra studie-ID-nummer
- 12-403A
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