Aripiprazole in the Treatment of Irritability in Children and Adolescents With Autistic Disorder

被引:392
作者
Owen, Randall [1 ]
Sikich, Linmarie [2 ]
Marcus, Ronald N. [1 ]
Corey-Lisle, Patricia [1 ]
Manos, George [1 ]
McQuade, Robert D. [3 ]
Carson, William H. [3 ]
Findling, Robert L. [4 ]
机构
[1] Bristol Myers Squibb Co, Wallingford, CT 06492 USA
[2] Univ N Carolina, Sch Med, Chapel Hill, NC USA
[3] Otsuka Pharmaceut Dev & Commercializat Inc, Princeton, NJ USA
[4] Case Western Reserve Univ, Univ Hosp Case Med Ctr, Cleveland, OH 44106 USA
关键词
aripiprazole; autistic disorder; pediatrics; PERVASIVE DEVELOPMENTAL DISORDERS; OPEN-LABEL; RELIABILITY; VERSION; SCALE;
D O I
10.1542/peds.2008-3782
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
OBJECTIVE: The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these. METHODS: This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6-17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score (CGI-I). Safety and tolerability were also assessed. RESULTS: Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8. CONCLUSIONS: Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated. Pediatrics 2009;124:1533-1540
引用
收藏
页码:1533 / 1540
页数:8
相关论文
共 21 条
  • [11] [Gay W. Health P.R.B.N.I.o.M. Health P.R.B.N.I.o.M.], 1976, ECDEU Assessment Manual for Psychopharmacology, Revised, US Dept Health, Education, and Welfare publication (ADM), P534
  • [12] Guy W., 1976, CLIN GLOBAL IMPRESSI
  • [13] Behavioral and emotional problems in young people with pervasive developmental disorders: Relative prevalence, effects of subject characteristics, and empirical classification
    Lecavalier, Luc
    [J]. JOURNAL OF AUTISM AND DEVELOPMENTAL DISORDERS, 2006, 36 (08) : 1101 - 1114
  • [14] AUTISM DIAGNOSTIC INTERVIEW-REVISED - A REVISED VERSION OF A DIAGNOSTIC INTERVIEW FOR CAREGIVERS OF INDIVIDUALS WITH POSSIBLE PERVASIVE DEVELOPMENTAL DISORDERS
    LORD, C
    RUTTER, M
    LECOUTEUR, A
    [J]. JOURNAL OF AUTISM AND DEVELOPMENTAL DISORDERS, 1994, 24 (05) : 659 - 685
  • [15] Risperidone in children with autism and serious behavioral problems
    McCracken, JT
    McGough, J
    Shah, B
    Cronin, P
    Hong, D
    Aman, MG
    Arnold, E
    Lindsay, R
    Nash, P
    Hollway, J
    McDougle, CJ
    Posey, D
    Swiezy, N
    Kohn, A
    Scahill, L
    Martin, A
    Koenig, K
    Volkmar, F
    Carroll, D
    Lancor, A
    Tierney, E
    Ghuman, J
    Gonzalez, NM
    Grados, M
    Vitiello, B
    Ritz, L
    Davies, M
    Robinson, J
    McMahon, D
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2002, 347 (05) : 314 - 321
  • [16] Management of children with autism spectrum disorders
    Myers, Scott M.
    Johnson, Chris Plauche
    [J]. PEDIATRICS, 2007, 120 (05) : 1162 - 1182
  • [17] Children's Yale-Brown obsessive compulsive scale: Reliability and validity
    Scahill, L
    Riddle, MA
    McSwigginHardin, M
    Ort, SI
    King, RA
    Goodman, WK
    Cicchetti, D
    Leckman, JF
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY, 1997, 36 (06) : 844 - 852
  • [18] Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders
    Shea, S
    Turgay, A
    Carroll, A
    Schulz, M
    Orlik, H
    Smith, I
    Dunbar, F
    [J]. PEDIATRICS, 2004, 114 (05) : E634 - E641
  • [19] SIMPSON GM, 1970, ACTA PSYCHIAT SCAND, P11
  • [20] PedsQL™ 4.0:: Reliability and validity of the pediatric quality of life Inventory™ Version 4.0 generic core scales in healthy and patient populations
    Varni, JW
    Seid, M
    Kurtin, PS
    [J]. MEDICAL CARE, 2001, 39 (08) : 800 - 812