Early-Onset Schizophrenia | Bipolar I Disorder, Manic or Mixed Episode | Aggressive Behaviors Associated With Autism Spectrum Disorders, Disruptive Behavior Disorders, ADHD, and Mental Retardation/Subaverage IQ | Tourette's Syndrome
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.