Clinical trials of antipsychotic drugs traditionally focus on acute clinical efficacy and tolerability. However, pharmacological interventions in children and adolescents with mental disorders must meet broader requirements of clinical effectiveness to provide the best possible outcome in terms of individual well-being, social and educational and/or vocational functioning, and disease burden. They must also take into account long-term safety issues and the possible interaction of the drugs with a developing brain. Developmental changes occurring during childhood and adolescence may influence both treatment response and drug tolerability in ways not seen in adults. It is also possible that treatment may adversely affect cognitive development, exacerbating functional problems and limiting clinical effectiveness. Alternatively, early intervention with an effective and well-tolerated antipsychotic may provide benefits that may modify the actual course of the disease in some paediatric mental disorders (Arango et al., 2004).
Antipsychotics have shown efficacy in the treatment of psychotic disorders in children and adolescents (schizophrenia, bipolar disorders), as well as conduct disorders, Tourette syndrome, and tics (Jensen et al., 2007; Kumra et al., 2008; Findling et al., 2008). In the first study comparing 3 different second-generation antipsychotics (SGAs) in 110 patients with early onset psychosis (mean
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European College of Neuropsychopharmacology