P.7.d.012 Paliperidone palmitate long-acting injection in adolescents: report of two cases

Abstract

were retrospectively investigated in order to assess tolerability and efficacy of medications. Diagnoses were estabilished according to DSM-IV-TR criteria. Clinical reports of adverse effects, laboratory indices, vital signs and outcome measures were analyzed at baseline and 1, 3 and 6 months after. Putative quetiapine/aripiprazole-related adverse effects were grouped into six categories: Central Nervous System (including Extrapyramidal symptoms, EPS, and headache/dizziness), Psychic symptoms (including somnolence/sedation, poor attention), Gastrointestinal system (i.e. nausea, vomiting), Endocrine System (i.e. hyperprolactinemia), Metabolic System (i.e. increased appetite and weight gain) and Miscellaneus Adverse Effect (i.e. hypotension, allergic reaction, urinary incontinence). Outcome measures included the Brief Psychiatric Rating Scale (BPRS), the Children Global Assessment Scale (C-GAS) and the Clinical Global Impression Severity (CGI-S). Categorical comparisons were based on contingency tables (c2). Continuous variables were compared by T Test. Correlation was used to investigate whether specific diagnosis, gender, age at index episode/ starting the therapy, cognitive level, daily dose (mg/die), duration of the therapy (months) may predict the development of a specific group of adverse events. ANOVA repeated measures and ANCOVA were performed for outcome measures at 1, 3, 6 month follow up. Results: Mean duration for quetiapine therapy was 11.5 months (SD 12.5), for aripiprazole was 13.9 months (SD 13.8). 71.1% of subjects on quetiapine (n 32) and 78.6% on aripiprazole (n 22) reported at least one adverse events; 3 patients belonging to each group (respectively 6.6% and 10.7%) discontinued therapy for an adverse event (quetiapine: 1 somnolence and 2 possible allergic reaction; aripiprazole: 1 somnolence and 2 acute dystonia). Psychic adverse events were observed in 23 patients (51.1%) for quetiapine and 9 patient (32.1%) for aripiprazole: 96% of patients belonging to each group reported somnolence as the main psychic adverse event, 3 subjects on aripiprazole reported poor attention. Psychic adverse event resulted mainly correlated to Major Depression/Mood Disorder nos (r = 0.338, p = 0.023) for quetiapine and to Bipolar disorder for aripiprazole (r = 0.365; p = 0.056). EPS adverse events were observed in 13 patients (46.4%) for aripiprazole and 5 patients (11.1%) for quetiapine: they were mainly related to Bipolar Disorder diagnosis (r = 0.293; p = 0.051) and worst functioning (C-GAS r = −0.445, p = 0.002; CGI-S r = 0.402, p = 0.006). Significant changes in symptomatology with a considerable improvement were assessed after quetiapine and aripirazole treatment both in BPRS’ scores (42.03±16.3 vs 28.04±19.1 after 1 month for quetiapine and 52.8±27.1 vs 37.2±21.4 after 1 month for aripiprazole) and C-GAS’ scores (34.55±4.83 vs 49.41±12.91 after 6 months; C-GAS 34.32±5.47 vs 43.21±8.93 after 6 months). Conclusions: This study suggests that quetiapine and aripiprazole are effective and relatively well-tolerated treatment in children and adolescents with different psychiatric diagnoses. Additional studies using head-to-head comparisons and a larger number of patients are needed for a better understanding of these drugs. P.7.d.012 Paliperidone palmitate long-acting injection in adolescents: report of two cases