Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: A 52-week, open-label, multicenter study

Journal of Clinical Psychiatry

Volumn 72, Issue 9, 2011, Pages 1270-1276

  Marcus, Ronald N ^a   Owen, Randall ^a   Manos, George ^a   Mankoski, Raymond ^b   Kamen, Lisa ^a   McQuade, Robert D ^c   Carson, William H ^c   Findling, Robert L ^d  

^a BRISTOL MYERS SQUIBB   (United States)

^b Otsuka Pharmaceutical Development and Commercialization Inc ^*

^c OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC   (United States)

^d UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARIPIPRAZOLE; GLUCOSE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; TRIACYLGLYCEROL;

ADOLESCENT; AGGRESSION; AGITATION; AKATHISIA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANXIETY DISORDER; APPETITE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; AUTISM; BODY MASS; CHILD; CHOLESTEROL BLOOD LEVEL; CONSTIPATION; CONTROLLED STUDY; COUGHING; DIARRHEA; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSKINESIA; DYSMENORRHEA; EAR INFECTION; ENURESIS; EPISTAXIS; EXTRAPYRAMIDAL SYMPTOM; FATIGUE; FEMALE; FEVER; GLUCOSE BLOOD LEVEL; HUMAN; HYPERSALIVATION; INSOMNIA; IRRITABILITY; LETHARGY; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; NAUSEA; NOSE CONGESTION; PRESCHOOL CHILD; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; PSYCHOMOTOR DISORDER; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCHOOL CHILD; SEDATION; SIDE EFFECT; SINUSITIS; SOMNOLENCE; TIC; TREATMENT DURATION; TREMOR; TRIACYLGLYCEROL BLOOD LEVEL; UPPER RESPIRATORY TRACT CONGESTION; UPPER RESPIRATORY TRACT INFECTION; VAGINITIS; VIRAL GASTROENTERITIS; VOMITING; WEIGHT GAIN;

EID: 80052989828     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.09m05933     Document Type: Article

References (18)

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000.
2. Volkmar F, Cook E Jr, Pomeroy J, et al American Academy of Child and Adolescent Psychiatry. Summary of the Practice Parameters for the Assessment and Treatment of Children, Adolescents, and Adults with Autism and other Pervasive Developmental Disorders. J Am Acad Child Adolesc Psychiatry. 1999;38(12):1611-1616. doi:10.1097/04583-19120-028 PubMed
3. Myers SM, Johnson CP; American Academy of Pediatrics Council on Children With Disabilities. Management of children with autism spectrum disorders. Pediatrics. 2007;120(5):1162-1182. doi:10.1542/peds.207-2362 PubMed (Pubitemid 350085560)
4. Aripiprazole [package insert]. Princeton, NJ: Bristol-Myers Squibb; and Rockville, MD; Otsuka America Pharmaceutical, Inc. Revised November 2009.
5. Risperidone [package insert]. Titusville, NJ: Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals Inc. Revised July 2009.
6. Marcus RN, Owen R, Kamen L, et al. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009;48(11):1110-1119. doi:10.1097/CHI.0b013e3181b7658 PubMed
7. Greenaway M, Elbe D. Focus on aripiprazole: a review of its use in child and adolescent psychiatry. J Can Acad Child Adolesc Psychiatry. 2009;18(3):250-260. PubMed
8. Marcus RN, Owen R, Manos G, et al. Aripiprazole in the Treatment of Irritability in Pediatric Patients (aged 6-17 years) with Autistic Disorder: Results from a 52-Week, Open-Label Study. J Child Adolesc Psychopharmacol. In press.
9. Owen R, Sikich L, Marcus RN, et al. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics. 2009;124(6):1533-1540. doi:10.1542/peds.208-3782 PubMed
10. Lord C, Rutter M, Le Couteur A. Autism Diagnostic Interview-Revised: a revised version of a diagnostic interview for caregivers of individuals with possible pervasive developmental disorders. J Autism Dev Disord. 1994;24(5):659-685. doi:10.107/BF02172145 PubMed (Pubitemid 24309810)
11. Aman MG, Singh NN, Stewart AW, et al. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985;89(5):485-491. PubMed (Pubitemid 15104762)
12. Simpson GM, Angus JW. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand suppl. 1970;45(S212):11-19. doi:10.1/j.160-047.1970.tb0206. x PubMed
13. Barnes TR. A rating scale for drug-induced akathisia. Br J Psychiatry. 1989;154(5):672-676. doi:10.192/bjp.154.5.672 PubMed (Pubitemid 19154942)
14. Guy W. Abnormal Involuntary Movement Scale (AIMS). ECDEU Assessment Manual for Psychopharmacology. US Department of Health, Education, and Welfare publication (ADM) 76-338. Rockville, MD: National Institute of Mental Health; 1976:534-537.
15. Ogden CL, Kuczmarski RJ, Flegal KM, et al. Centers for Disease Control and Prevention 2000 growth charts for the United States: improvements to the 1977 National Center for Health Statistics version. Pediatrics. 2002;109(1):45-60. doi:10.1542/peds.109.1.45 PubMed (Pubitemid 34049426)
16. Correll CU. Assessing and maximizing the safety and tolerability of antipsychotics used in the treatment of children and adolescents. J Clin Psychiatry. 2008;69(suppl 4):26-36. PubMed
17. Anderson GM, Scahill L, McCracken JT, et al. Effects of short- and longterm risperidone treatment on prolactin levels in children with autism. Biol Psychiatry. 2007;61(4):545-550. doi:10.1016/j.biopsych.206.02.032 PubMed (Pubitemid 46185331)
18. American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists, et al. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27(2):596-601. doi:10.237/diacare.