Objectives: To study the efficacy and safety of olanzapine for the treatment of children with autism associated with disruptive behavior problems. Subjects and Methods: A prospective open-label trial was conducted on 40 male children (mean age 12.2 ± 2.2 years, range 7–17 years) meeting Diagnostic Statistical Manual IV criteria for autism. After a washout period from previous medications (2–14 days), patients received olanzapine (5–10 mg/day) for a 13-week treatment period. The primary efficacy measures were Aberrant Behavior Checklist (ABC) and Clinical Global Impressions-Severity (CGI-S) done at baseline and end of treatment. At the beginning and end of treatment, patients underwent laboratory and physical investigations: ECG, chest X-ray, urinalysis, serum chemistry, blood glucose and lipid profile, hematology and hepatitis B serology. Results: Paired comparison of baseline and 13-week endpoint scores showed significant reductions in ABC subscale scores for irritability (p < 0.0001), lethargy (p < 0.0001), stereotyped behavior (p < 0.005), hyperactivity (p < 0.0001) and inappropriate speech (p < 0.005). Of 40 patients, 12 (30%) were considered as ‘improved’ on CGI-S scores compared to baseline, a statistically significant difference (p < 0.05). No liver enzyme elevation or any other serum biochemical changes resulted from treatment, which was not associated with significant body weight changes or any other treatment-emergent side effects. Conclusions: The study shows that olanzapine treatment can be beneficial in alleviating some behavioral symptoms (irritability, hyperactivity/noncompliance and lethargy/withdrawal) associated with autism. The short period of this trial limits inferences about adverse effects such as body weight increase and tardive dyskinesia. Further long-term placebo-controlled studies of olanzapine are required.
© 2008 S. Karger AG, Basel
- Atypical antipsychotic agent
- Kuwait, clinical trial
- American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, ed 4. Washington, American Psychiatric Association, 2002.
- Frombonne E: Epidemiological surveys of autism and other pervasive developmental disorders: an update. J Autism Dev Disord 2003;33:365–382.
- The Annual Statistical Abstract. Kuwait Autism Society 2006;2:51–58.
- Bailey A, Lecouteur A, Gottesman J: Autism as a strongly genetic disorder: evidence from a British twin study. Psychol Med 1995;25:63–77.
- Piven J, Palmer P, Jacobi D: The broader autism phenotype: evidence from a family study of multiple-incidence autism families. Am J Psychiatry 1997;154:185–190.
- Sykes NH, Lamb JS: Autism: the quest for the genes. Expert Rev Mol Med 2007;9:1–15.
- Whitely P: A gluten-free diet as an intervention for autism and associated spectrum disorders: preliminary findings. Autism 1999;3:45–65.
- Murch S: Diet, immunity, and autistic spectrum disorders. J Pediatr 2005;146:582–584.
- Janusonis S: Statistical distribution of blood serotonin as a predictor of early autistic brain abnormalties. Theor Biol Med Model 2007;19:2–27.
- Fido A, Dashti H, Al-Saad S: Biological correlates of childhood autism: ‘trace elements’. Trace Elem Electrol 2002;19:1–4.
- Fido A, Al-Saad S: Toxic trace elements in the hair of children with autism. Autism 2005;9:290–298.
- Dosman CF, Brian JA, Drmic IE: Children with autism: effect of iron supplementation on sleep and ferritin. Pediatr Neurol 2007;36:152–158.
- Adams JB, Romdalvik J, Ramanujam VM: Mercury, lead, and zinc in baby teeth of children with autism versus controls. J Toxicol Environ Health 2007;70:1046–1051.
- Horner RH, Carr EG, Strain PS: Problem behavior interventions for young children with autism: a research synthesis. J Autism Dev Disord 2002;32:423–446.
- Hagopian LP, Pruzek JL, Bowman LG: Assessment and treatment of problem behavior occasioned by interruption of free-operant behavior. J Appl Behav Anal 2007;40:89–103.
- Jerome J, Frantino E, Sturmey P: The effects of errorless learning and backward chaining on the acquisition of internet skills in adults with developmental disabilities. J Appl Behav Anal 2007;40:185–189.
- Posey DJ, McDougle CJ: The pharmacotherapy of target symptoms associated with autistic disorder and other pervasive developmental disorders. Harv Rev Psychiatry 2000;8:45–63.
- Aman MG: Management of hyperactivity and other acting-out problems in patients with autism spectrum disorder. Semin Pediatr Neurol 2004;11:225–228.
- Malone R, Maislin G, Choudhury M: Risperidone treatment in children and adolescents with autism: short-and long-term safety and effectiveness. Am Acad Child Adolesc Psychiatry 2002;41:140–147.
- McCracken J, Mcgough J, Shah B: Risperidone in children with autism and serious behavioral problems. N Engl J Med 2002;347:314–321.
- Padina GJ, Bossie CA, Yousef E: Risperidone improves symptoms in children with autism in a randomized, double-blind, placebo-controlled trial. Autism Dev Disord 2007;37:367–373.
- West L, Waldrop J: Risperidone use in the treatment of behavioral symptoms in children with autism. Pediatr Nursing 2006;32:550–555.
- Potenza MN, Holmes JP, Kanes SJ: Olanzapine treatment of children, adolescents, and adults with pervasive developmental disorders: an open-label pilot study. J Clin Psychopharmacol 1999;19:37–44.
- Malone R, Cater J, Sheikh R: Olanzapine versus haloperidol in children with autistic disorder: an open pilot study. J Am Child Adolesc 2001;40:887–894.
- Kemner C, Willemsen S, Sophie H: Open-label study of olanzapine in children with pervasive developmental disorder. J Clin Psychopharmacol 2002;22:455–460.
- Barnes TR: A rating scale for drug-induced akathisia. Br J Psychiatry 1989;154:672–676.
- Aman MG, Singh NN, Stewart AW: The Aberrant Behavior Checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic 1985;89:485–491.
- Hollander E, Wasserman S, Swanson EN: A double-blind placebo-controlled pilot study of olanzapine in childhood/adolescent pervasive developmental disorder. J Child Adolesc Psychopharmacol 2006;16:541–548.
Dr. Abdullahi Fido, MD, MRCPsych
Department of Psychiatry, Faculty of Medicine, Health Sciences Centre
Kuwait University, PO Box 24923
Safat 13110 (Kuwait)
Tel. +965 533 0467, Fax +965 533 8904, E-Mail email@example.com
Received: July 18, 2007
Revised: October 9, 2007
Published online: August 06, 2008
Number of Print Pages : 4
Number of Figures : 0, Number of Tables : 1, Number of References : 28
Medical Principles and Practice (International Journal of the Kuwait University Health Sciences Centre)
Vol. 17, No. 5, Year 2008 (Cover Date: August 2008)
Journal Editor: Owunwanne A. (Kuwait)
ISSN: 1011–7571 (Print), eISSN: 1423–0151 (Online)
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