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Title: A Prospective Open-Label Trial of Paliperidone Monotherapy in Youth with Anger Outburst
Authors: I, Lee Fu-BOARATI, Miguel A.
Citation: BIOLOGICAL PSYCHIATRY, v.73, n.9, suppl.S, p.46S-46S, 2013
Abstract: Background: The safety, efficiency and tolerability of paliperidone 24hs release formulation (OROS®) have been demonstrated through clinical trials as treatment alternative for several psychiatric condition in adults. However, scarce study has reported the usefulness of youths. Objective: To evaluate the safety and efficacy of paliperidone OROS® monotherapy as an acute treatment of anger outburst for children and adolescents and related condition (depression, bipolar spectrum symptoms, ADHD). Methods: This was an three-month, open-label, prospective trial of paliperidone monotherapy to assess the effectiveness and tolerability of this compound in treating frequently and severe dysfunctional anger outburst. Assessments included the clinical interview, Children’s Behavior Checklist, and Diagnostic Interview for Children and Adolescents. Clinical response to paliperidone was evaluated using the Children’s Global Assessment Scale (CGAS) and Clinical Global Impression scale (CGI) across four time periods: index time (T0), 4 weeks after (T1), 8 weeks after (T2) and 12 weeks after (T3). Results: Fourteen patients, age 06 to 14 years-old, both genders, receiving paliperidone OROS® presented considerable improvement in global functioning (CGAS at entry: 25.1±5; and at T3 = 58.2±5) and CGI mean scores also show significant clinical improvement at the endpoint. Paliperidone was titrated from an initial dose of 3 mg/day to a dose of 6 mg/day. There were no significant changes in laboratory measurements and weight throughout follow-up. Conclusions: Paliperidone OROS® demonstrated to be an alternative treatment for acute uncontrolled and dysfunctional anger outburst and associated conditions for children and adolescents. Further controlled studies are necessary to confirm these initial findings.
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Comunicações em Eventos - HC/IPq
Instituto de Psiquiatria - HC/IPq

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