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Gepubliceerd in: Journal of Autism and Developmental Disorders 3/2012

01-03-2012 | original paper

Design and Subject Characteristics in the Federally-Funded Citalopram Trial in Children with Pervasive Developmental Disorders

Auteurs: Lawrence Scahill, James T. McCracken, Karen Bearss, Fay Robinson, Eric Hollander, Bryan King, Joel Bregman, Lin Sikich, Kimberly Dukes, Lisa Sullivan, Evdokia Anagnostou, Craig Donnelly, Young-Shin Kim, Louise Ritz, Deborah Hirtz, Ann Wagner

Gepubliceerd in: Journal of Autism and Developmental Disorders | Uitgave 3/2012

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Abstract

The Studies to Advance Autism Research and Treatment Network conducted a randomized trial with citalopram in children with Pervasive developmental disorders (PDDs). We present the rationale, design and sample characteristics of the citalopram trial. Subjects (128 boys, 21 girls) had a mean age of 9.3 (±3.12) years; 132 (88.6%) were diagnosed with autistic disorder (4.7% with Asperger’s Disorder; 6.7% with PDD-not otherwise specified). Less than half of the subjects were intellectually disabled; 117 (78.5%) were rated Moderate or Marked on the Clinical Global Impression for Severity. Study measures were similar to previous Research Units on Pediatric Psychopharmacology trials. Subjects in this trial were slightly older and more likely to have complaints of repetitive behavior than participants in RUPP trials.
Literatuur
go back to reference Aman, M. G., McDougle, C. J., Scahill, L., Handen, B., Arnold, L. E., Johnson, C., et al. (2009). Medication and parent training in children with pervasive developmental disorders and serious behavioral problems. Journal of the American Academic Child Adolescent Psychiatry, 49(12), 1143–1154.CrossRef Aman, M. G., McDougle, C. J., Scahill, L., Handen, B., Arnold, L. E., Johnson, C., et al. (2009). Medication and parent training in children with pervasive developmental disorders and serious behavioral problems. Journal of the American Academic Child Adolescent Psychiatry, 49(12), 1143–1154.CrossRef
go back to reference Arnold, L. E., Vitiello, B., McDougle, C. J., Scahill, L., Shah, B., Gonzalez, N. M., et al. (2003). Parent-defined target symptoms respond to risperidone in RUPP autism study: Customer approach to clinical trials. Journal of the American Academy of Child Psychiatry, 42(12), 1443–1450.CrossRef Arnold, L. E., Vitiello, B., McDougle, C. J., Scahill, L., Shah, B., Gonzalez, N. M., et al. (2003). Parent-defined target symptoms respond to risperidone in RUPP autism study: Customer approach to clinical trials. Journal of the American Academy of Child Psychiatry, 42(12), 1443–1450.CrossRef
go back to reference American Psychiatric Association. (1994). Diagnostic and statistical manual of mental disorders (4th ed.). Washington: American Psychiatric Association. American Psychiatric Association. (1994). Diagnostic and statistical manual of mental disorders (4th ed.). Washington: American Psychiatric Association.
go back to reference Brown, E. C., Aman, M. G., & Havercamp, S. M. (2002). Factor analysis and norms for parent ratings on the aberrant behavior checklist-community for young people in special education. Research in Developmental Disabilities, 23, 45–60.PubMedCrossRef Brown, E. C., Aman, M. G., & Havercamp, S. M. (2002). Factor analysis and norms for parent ratings on the aberrant behavior checklist-community for young people in special education. Research in Developmental Disabilities, 23, 45–60.PubMedCrossRef
go back to reference Collins, L. M., Murphy, S. A., & Strecher, V. (2007). The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): New methods for more potent e-Health interventions. American Journal of Preventive Medicine, 32(5 Suppl), S112–S118.PubMedCrossRef Collins, L. M., Murphy, S. A., & Strecher, V. (2007). The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): New methods for more potent e-Health interventions. American Journal of Preventive Medicine, 32(5 Suppl), S112–S118.PubMedCrossRef
go back to reference Correll, C. U., Manu, P., Olshanskiy, V., Napolitano, B., Kane, J. M., & Malhotra, A. K. (2009). Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents. JAMA, 302(16), 1765–1773.PubMedCrossRef Correll, C. U., Manu, P., Olshanskiy, V., Napolitano, B., Kane, J. M., & Malhotra, A. K. (2009). Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents. JAMA, 302(16), 1765–1773.PubMedCrossRef
go back to reference Developmental Autism Disabilities Monitoring Network Surveillance Principal Investigators. (2007). Prevalence of autism spectrum disorders—autism and developmental disabilities monitoring network, 14 Sites, united states, 2002. Morbidity and Mortality Weekly Report, 56, 12–28. Developmental Autism Disabilities Monitoring Network Surveillance Principal Investigators. (2007). Prevalence of autism spectrum disorders—autism and developmental disabilities monitoring network, 14 Sites, united states, 2002. Morbidity and Mortality Weekly Report, 56, 12–28.
go back to reference Dolen, G., & Bear, M. F. (2008). Role for metabotropic glutamate receptor 5 (mGluR5) in the pathogenesis of fragile X syndrome. Journal of Physiology, 586(6), 1503–1508.PubMedCrossRef Dolen, G., & Bear, M. F. (2008). Role for metabotropic glutamate receptor 5 (mGluR5) in the pathogenesis of fragile X syndrome. Journal of Physiology, 586(6), 1503–1508.PubMedCrossRef
go back to reference Fombonne, E. (2005). Epidemiology of autistic disorder and other pervasive developmental disorders. Journal of Clinical Psychiatry, 6, 3–8. Fombonne, E. (2005). Epidemiology of autistic disorder and other pervasive developmental disorders. Journal of Clinical Psychiatry, 6, 3–8.
go back to reference Gadow, K. D., & Sprafkin, J. (2002). Child symptom inventory–4 screening and norms manual. Stony Brook: Checkmate Plus. Gadow, K. D., & Sprafkin, J. (2002). Child symptom inventory–4 screening and norms manual. Stony Brook: Checkmate Plus.
go back to reference Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Washington: DHEW, NIMH. Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Washington: DHEW, NIMH.
go back to reference Jahromi, L. B., Kasari, C. L., McCracken, J. T., LS-, Lee., Aman, M. G., McDougle, C. J., et al. (2008). Positive effects of methylphenidate on social communication and self-regulation in children with pervasive developmental disorders and hyperactivity. Journal Autism Develop Disorders, 38(3), 395–404. Jahromi, L. B., Kasari, C. L., McCracken, J. T., LS-, Lee., Aman, M. G., McDougle, C. J., et al. (2008). Positive effects of methylphenidate on social communication and self-regulation in children with pervasive developmental disorders and hyperactivity. Journal Autism Develop Disorders, 38(3), 395–404.
go back to reference King, B. H., Hollander, E., Sikich, L., McCracken, J. T., Scahill, L., Bregman, J. D., et al. (2009). Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior. Archives of General Psychiatry, 66(6), 583–590.PubMedCrossRef King, B. H., Hollander, E., Sikich, L., McCracken, J. T., Scahill, L., Bregman, J. D., et al. (2009). Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior. Archives of General Psychiatry, 66(6), 583–590.PubMedCrossRef
go back to reference Kraemer, H. C., Mintz, J., Noda, A., Tinklenberg, J., & Yesavage, J. A. (2006). Caution regarding the use of pilot studies to guide power calculations for study proposals. Archives of General Psychiatry, 63(5), 484–489.PubMedCrossRef Kraemer, H. C., Mintz, J., Noda, A., Tinklenberg, J., & Yesavage, J. A. (2006). Caution regarding the use of pilot studies to guide power calculations for study proposals. Archives of General Psychiatry, 63(5), 484–489.PubMedCrossRef
go back to reference Lecavalier, L. (2006). Behavior and emotional problems in young people with PDD: Relative prevalence, effects of subject characteristics, and empirical classification. Journal Autism Develop Disorders, 36, 1101–1114.CrossRef Lecavalier, L. (2006). Behavior and emotional problems in young people with PDD: Relative prevalence, effects of subject characteristics, and empirical classification. Journal Autism Develop Disorders, 36, 1101–1114.CrossRef
go back to reference Lord, C., Rutter, M., & LeCouteur, A. (1994). Autism diagnostic interview–revised: A revised version of a diagnostic interview for caregivers of individuals with possible pervasive developmental disorders. Journal Autism Develop Disorders, 24, 659–685.CrossRef Lord, C., Rutter, M., & LeCouteur, A. (1994). Autism diagnostic interview–revised: A revised version of a diagnostic interview for caregivers of individuals with possible pervasive developmental disorders. Journal Autism Develop Disorders, 24, 659–685.CrossRef
go back to reference Martin, A., Scahill, L., Anderson, G. M., Aman, M., Arnold, L. E., McCracken, J., et al. (2004). Weight and leptin changes among risperidone-treated youths with autism: 6 month prospective data. American Journal of Psychiatry, 161(6), 1125–1127.PubMedCrossRef Martin, A., Scahill, L., Anderson, G. M., Aman, M., Arnold, L. E., McCracken, J., et al. (2004). Weight and leptin changes among risperidone-treated youths with autism: 6 month prospective data. American Journal of Psychiatry, 161(6), 1125–1127.PubMedCrossRef
go back to reference McDougle, C. J., Scahill, L., Aman, M. G., McCracken, J. T., Tierney, E., Davies, R., et al. (2005). Risperidone for the core symptom domains of autism: Results from the study by the autism network of the research units on pediatric psychopharmacology. American Journal of Psychiatry, 162, 1142–1148.PubMedCrossRef McDougle, C. J., Scahill, L., Aman, M. G., McCracken, J. T., Tierney, E., Davies, R., et al. (2005). Risperidone for the core symptom domains of autism: Results from the study by the autism network of the research units on pediatric psychopharmacology. American Journal of Psychiatry, 162, 1142–1148.PubMedCrossRef
go back to reference Molloy, C. A., & Manning-Courtney, P. (2003). Prevalence of chronic gastrointestinal symptoms in children with autism and autistic spectrum disorders. Autism, 7(2), 165–171.PubMedCrossRef Molloy, C. A., & Manning-Courtney, P. (2003). Prevalence of chronic gastrointestinal symptoms in children with autism and autistic spectrum disorders. Autism, 7(2), 165–171.PubMedCrossRef
go back to reference Mullen, E. (1995). The mullen scales of early learning. Circle Pines: American Guidance Service. Mullen, E. (1995). The mullen scales of early learning. Circle Pines: American Guidance Service.
go back to reference Nikolov, R. N., Bearss, K. E., Lettinga, J., Erickson, C., Rodowski, M., Aman, M. G., et al. (2009). Gastrointestinal symptoms in a sample of children with pervasive developmental disorders. Journal Autism Develop Disorders, 39(3), 405–413.CrossRef Nikolov, R. N., Bearss, K. E., Lettinga, J., Erickson, C., Rodowski, M., Aman, M. G., et al. (2009). Gastrointestinal symptoms in a sample of children with pervasive developmental disorders. Journal Autism Develop Disorders, 39(3), 405–413.CrossRef
go back to reference Research Units on Pediatric Psychopharmacology Autism Network. (2005). A randomized controlled crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Archives of General Psychiatry, 62, 1266–1274.CrossRef Research Units on Pediatric Psychopharmacology Autism Network. (2005). A randomized controlled crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Archives of General Psychiatry, 62, 1266–1274.CrossRef
go back to reference Roid, G. H., & Miller, L. (1997). Leiter international performance scale-revised: Examiner’s manual. In G. H. Roid & L. J. Miller (Eds.), Leiter international performance scale-revised. Wood Dale: Stoelting Co. Roid, G. H., & Miller, L. (1997). Leiter international performance scale-revised: Examiner’s manual. In G. H. Roid & L. J. Miller (Eds.), Leiter international performance scale-revised. Wood Dale: Stoelting Co.
go back to reference Rossignol, D. A. (2009). Novel and emerging treatments for autism spectrum disorders: A systematic review. Annals of Clinical Psychiatry, 21(4), 213–236.PubMed Rossignol, D. A. (2009). Novel and emerging treatments for autism spectrum disorders: A systematic review. Annals of Clinical Psychiatry, 21(4), 213–236.PubMed
go back to reference Sarhangian, R., Bearss, K., Scahill, L. (2009). For research units of pediatric psychopharmacology autism network. Parent-defined target symptoms in the RUPP Methylphenidate Trial. Presented at the Western Regional Medical School Research Conference, January 30, 2009, Carmel, California. Sarhangian, R., Bearss, K., Scahill, L. (2009). For research units of pediatric psychopharmacology autism network. Parent-defined target symptoms in the RUPP Methylphenidate Trial. Presented at the Western Regional Medical School Research Conference, January 30, 2009, Carmel, California.
go back to reference Scahill, L., & Lord, C. (2004). Subject selection and characterization in clinical trial in children with autism. CNS Spectrums, 9(1), 22–32.PubMed Scahill, L., & Lord, C. (2004). Subject selection and characterization in clinical trial in children with autism. CNS Spectrums, 9(1), 22–32.PubMed
go back to reference Scahill, L., Riddle, M. A., McSwiggin-Hardin, M., Ort, S. I., King, R. A., Goodman, W. K., et al. (1997). Children’s yale-brown obsessive compulsive scale: Reliability and validity. Journal of the American Academic Child Adolescen Psychiatry, 36(6), 844–852.CrossRef Scahill, L., Riddle, M. A., McSwiggin-Hardin, M., Ort, S. I., King, R. A., Goodman, W. K., et al. (1997). Children’s yale-brown obsessive compulsive scale: Reliability and validity. Journal of the American Academic Child Adolescen Psychiatry, 36(6), 844–852.CrossRef
go back to reference Scahill, L., McDougle, C. J., Williams, S. K., Dimitropoulos, A., Aman, M. G., McCracken, J., et al. (2006). The Children’s yale-brown obsessive compulsive scale modified for pervasive developmental disorders. Journal of the American Academy of Child and Adolescent Psychiatry, 45, 1114–1123.PubMedCrossRef Scahill, L., McDougle, C. J., Williams, S. K., Dimitropoulos, A., Aman, M. G., McCracken, J., et al. (2006). The Children’s yale-brown obsessive compulsive scale modified for pervasive developmental disorders. Journal of the American Academy of Child and Adolescent Psychiatry, 45, 1114–1123.PubMedCrossRef
go back to reference Scahill, L., Solanto, M., & McGuire, J. (2008). The science and ethics of placebo in pediatric psychopharmacology. Ethics and Behavior, 18, 266–285.CrossRef Scahill, L., Solanto, M., & McGuire, J. (2008). The science and ethics of placebo in pediatric psychopharmacology. Ethics and Behavior, 18, 266–285.CrossRef
go back to reference Scahill, L., Aman, M. G., McDougle, C. J., Arnold, L. E., McCracken, J. T., Handen, B., et al. (2009). Trial design challenges when combining medication and parent training in children with pervasive developmental disorders. Journal Autism Develop Disorders, 39(5), 720–729.CrossRef Scahill, L., Aman, M. G., McDougle, C. J., Arnold, L. E., McCracken, J. T., Handen, B., et al. (2009). Trial design challenges when combining medication and parent training in children with pervasive developmental disorders. Journal Autism Develop Disorders, 39(5), 720–729.CrossRef
go back to reference Slosson, R. L. (1983). Slosson intelligence test. East Aurora: Slosson educational publications. Slosson, R. L. (1983). Slosson intelligence test. East Aurora: Slosson educational publications.
go back to reference Sparrow, S., Balla, D., & Cicchetti, D. (1984). Vineland adaptive behavior scales. Circle Pines: American Guidance Service. Sparrow, S., Balla, D., & Cicchetti, D. (1984). Vineland adaptive behavior scales. Circle Pines: American Guidance Service.
go back to reference Sukhodolsky, D. G., Scahill, L., Gadow, K. D., Arnold, L. E., Aman, M. G., McDougle, C. J., et al. (2007). Parent-rated anxiety symptoms in children with pervasive developmental disorders: Frequency and association with core autism symptoms and cognitive functioning. Journal of Abnormal Child Psychology, 36(1), 117–128.PubMedCrossRef Sukhodolsky, D. G., Scahill, L., Gadow, K. D., Arnold, L. E., Aman, M. G., McDougle, C. J., et al. (2007). Parent-rated anxiety symptoms in children with pervasive developmental disorders: Frequency and association with core autism symptoms and cognitive functioning. Journal of Abnormal Child Psychology, 36(1), 117–128.PubMedCrossRef
go back to reference Research Units on Pediatric Psychopharmacology Autism Network. (2002). Risperidone in children with autism for serious behavioral problems. NEJM, 347, 314–321.CrossRef Research Units on Pediatric Psychopharmacology Autism Network. (2002). Risperidone in children with autism for serious behavioral problems. NEJM, 347, 314–321.CrossRef
go back to reference Valicenti-McDermott, M., McVicar, K., Rapin, I., Wershil, B. K., Cohen, H., & Shinnar, S. (2006). Frequency of gastrointestinal symptoms in children with autistic spectrum disorders and association with family history of autoimmune disease. Journal of Developmental & Behavioral Pediatrics, 27(2 Suppl), S128–S136.CrossRef Valicenti-McDermott, M., McVicar, K., Rapin, I., Wershil, B. K., Cohen, H., & Shinnar, S. (2006). Frequency of gastrointestinal symptoms in children with autistic spectrum disorders and association with family history of autoimmune disease. Journal of Developmental & Behavioral Pediatrics, 27(2 Suppl), S128–S136.CrossRef
go back to reference Wechsler, D. (1991). Manual for the wechsler intelligence scale for children (3rd ed.). San Antonio: Psychological Corporation. Wechsler, D. (1991). Manual for the wechsler intelligence scale for children (3rd ed.). San Antonio: Psychological Corporation.
go back to reference Wechsler, D. (2002). Manual for the wechsler preschool & primary scale for intelligence children— (3rd ed.). San Antonio: Psychological Corporation. Wechsler, D. (2002). Manual for the wechsler preschool & primary scale for intelligence children— (3rd ed.). San Antonio: Psychological Corporation.
Metagegevens
Titel
Design and Subject Characteristics in the Federally-Funded Citalopram Trial in Children with Pervasive Developmental Disorders
Auteurs
Lawrence Scahill
James T. McCracken
Karen Bearss
Fay Robinson
Eric Hollander
Bryan King
Joel Bregman
Lin Sikich
Kimberly Dukes
Lisa Sullivan
Evdokia Anagnostou
Craig Donnelly
Young-Shin Kim
Louise Ritz
Deborah Hirtz
Ann Wagner
Publicatiedatum
01-03-2012
Uitgeverij
Springer US
Gepubliceerd in
Journal of Autism and Developmental Disorders / Uitgave 3/2012
Print ISSN: 0162-3257
Elektronisch ISSN: 1573-3432
DOI
https://doi.org/10.1007/s10803-011-1251-8

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