Malone 2010.

Methods	Parallel trial of olanzapine versus placebo
Participants	Inclusion criteria: male and female aged 3‐12 years autistic disorder according to DSM‐IV criteria a score of at least moderately impaired on the CGI‐S clinical judgment that medication treatment for autism is indicated Exclusion criteria: Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS. psychotic disorder (DSM‐IV) (including schizophreniform disorder and schizophrenia). major depressive disorder (DSM‐IV). bipolar disorder (DSM‐IV). history of psychoactive drug in the previous 2 weeks prior to phase 1 history of treatment with olanzapine for a cumulative period of > 2 weeks prior to entering phase 1. systemic diseases such as cardiac, renal, thyroid diseases, uncontrolled seizure disorder (seizure disorder that is not controlled by anti‐epileptic medication ‐ a child who is seizure free for a period of 6 months on a stable dose of antiepileptic drug would be considered controlled), or diabetes mellitus children with a known medical cause for autistic disorder abnormal fasting blood glucose or history of diabetes baseline body mass index (BMI) > the 90th percentile for age and gender (CDC growth charts) (because of risk of weight gain) baseline QTc > 450 msec Location/setting: Drexel University, College of Medicine, Philadelphia, PA, USA Sample size: 33 Number of withdrawals/dropouts: none reported Gender: 25 male participants, 8 female participants Mean age: 6.58 years IQ: not reported Baseline ABC‐I or other BoC: not reported Concomitant medications: not reported History of previous medications: not reported
Interventions	Intervention (olanzapine) for 6 weeks: olanzapine tablets given twice daily at a dosage of 2.5‐20 mg/day for up to 12 weeks Comparator (placebo) for 6 weeks: matching placebo treatment
Outcomes	Primary outcomes: AEs Secondary outcomes: none reported Timing of outcome assessments: baseline and week 12
Notes	Study start date: May 2003 Study end date: September 2005 Source of funding: Food and Drug Administration (FD‐R‐002190), National Institute of Mental Health (MH073524). Placebo and drugs were provided by Eli Lilly Conflicts of interest: none declared