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Efficacy From Randomized Controlled Trials

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Eleven RCTs (N = 931) showed superior efficacy of antipsychotic monotherapy for pediatric schizophrenia (Kumra et al. 2008b). The study and patient characteristics and main efficacy outcomes, including study-defined response and remission, are summarized in Table 49–4. A clinically useful measure for the difference between treatment groups is the number needed to treat (NNT), which is the number of patients who need to be exposed to a treatment until one additional positive event of interest occurs in excess of the rate in the comparator. In an older 4-week placebo-controlled trial (Pool et al. 1976), haloperidol and loxapine were associated with significantly greater reductions in Brief Psychiatric Rating Scale (BPRS) scores compared to placebo, but there were no differences between the two active medication groups. In the other active-controlled studies with modest sample sizes not involving clozapine and lasting 4–8 weeks, antipsychotics did not show significant efficacy differences (Realmuto et al. 1984; Sikich et al. 2004, 2008). By contrast, in relatively small active-controlled trials, clozapine (mean dosage: 176–403 mg/day) was superior in several efficacy measures (especially negative symptoms) compared to haloperidol (Kumra et al. 1996), olanzapine (Shaw et al. 2006), and "high-dose" olanzapine (Kumra et al. 2008a). The NNTs for study-specific "response" in early-onset schizophrenia ranged from 5 to 8 with nonclozapine antipsychotics compared to placebo, and from 3 to 6 for clozapine compared to olanzapine.

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Table Reference Number
TABLE 49–4. Double-blind, randomized, placebo-controlled and active-controlled trials of antipsychotics in children and adolescents with schizophrenia
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TABLE 49–5. Double-blind, randomized, placebo-controlled trials of antipsychotics in children and adolescents with bipolar disorders
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TABLE 49–6. Double-blind, randomized, placebo-controlled and active-controlled trials of antipsychotics in children and adolescents with autism spectrum disorders
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TABLE 49–7. Double-blind, randomized, placebo-controlled trials of antipsychotics in children and adolescents with disruptive behavior disorders and Tourette's syndrome

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