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Among the patients included in the primary efficacy analysis, patients had a current co-morbid diagnosis of ADHD. Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS total score. In a post-hoc analysis, the improvement over placebo was more pronounced in the patients with associated co-morbidity of ADHD compared to the group without ADHD, where there was no difference from placebo.

Recurrence prevention was not established. The most common treatment-emergent adverse events among patients receiving 30 mg were extrapyramidal disorder Mean weight gain in the 30 weeks treatment-interval was 2. Irritability associated with autistic disorder in paediatric patients see section 4. However, the clinical relevance of this finding has not been established. The safety profile included weight gain and changes in prolactin levels.

The duration of the long-term safety study was limited to 52 weeks. In the placebo-controlled trials, the mean weight gain was 0. Aripiprazole was also studied in a placebo-controlled, long-term maintenance trial. The mean weight gain over the stabilisation phase up to 26 weeks on aripiprazole was 3. In both of these short-term trials, the clinical relevance of the efficacy findings has not been established, considering the magnitude of treatment effect compared to the large placebo effect and the unclear effects regarding psycho-social functioning.

No long-term data are available with regard to the efficacy and the safety of aripiprazole in this fluctuating disorder. Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 to 5 hours after dosing. Aripiprazole undergoes minimal pre-systemic metabolism. There is no effect of a high fat meal on the pharmacokinetics of aripiprazole.

Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4. Aripiprazole is the predominant medicinal product moiety in systemic circulation.

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