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Investigational Study Evaluates the Effectiveness of Aripiprazole,in Adolescents With Schizophrenia

iprazole metabolism. Agents that induce CYP3A4 (eg, carbamazepine) could cause an increase in aripiprazole clearance and lower blood levels. Inhibitors of CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, quinidine, fluoxetine, or paroxetine) can inhibit aripiprazole elimination and cause increased blood levels.

Commonly observed adverse events (greater than or equal to 5% incidence and at a rate at least twice the rate of placebo for aripiprazole vs placebo, respectively):

     Aripiprazole Oral

     In 3-week bipolar mania trials the following were reported: akathisia

     (15% vs 3%), constipation (13% vs 6%), sedation (8% vs 3%), tremor (7% vs

     3%), restlessness (6% vs 3%), and extrapyramidal disorder (5% vs 2%).

     In 4- to 6-week schizophrenia trials the following was reported:

     akathisia (8% vs 4%).

     A similar adverse event profile was observed in a 26-week trial in

     schizophrenia except for a higher incidence of tremor (aripiprazole 8% vs

     placebo 2%).


     Aripiprazole Injection

     In short-term (24 hour) trials in patients with agitation associated with

     schizophrenia or bipolar mania the following was reported: nausea (9% vs

     3%).


    Treatment-emergent adverse events reported with:


     Aripiprazole Oral

     In short-term trials of patients with schizophrenia (up to 6 weeks) or

     bipolar disorder (up to 3 weeks), the following were reported at an

     incidence greater than or equal to 10% and greater than placebo,

     respectively: headache (30% vs 25%), anxiety (20% vs 17%), insomnia (19%

     vs 14%), nausea (16% vs 12%), vomiting (12% vs 6%), dizziness (11% vs

     8%), constipation (11% vs 7%), dyspepsia (10% vs 8%), and akathisia (10%

     vs 4%).


     Aripiprazole Injection

     In short-term (24 hour) trials, the following were reported at an

     incidence greater than or equal to 5% and greater than placebo,

     respectively: headache (12% vs 7%), nausea (9% vs 3%), dizz
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