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| |  Aripiprazole Improves Quality of Life Measurements in Adolescents With Schizophrenia or Bipolar Disorder: Presented at AACAP By Deborah Brauser HONOLULU -- November 12, 2009 -- Aripiprazole can improve quality of life (QOL) in adolescents with schizophrenia or paediatric bipolar I disorder, according to post hoc analysis from 2 large randomised trials. The results were presented in a poster session here on October 31 by Suja Mathew, Otsuka America Pharmaceutical Inc, Rockville, Maryland, at the American Academy of Child and Adolescent Psychiatry (AACAP) 56th Annual Meeting. A growing body of evidence supports the importance of evaluating QOL alongside measures of symptom severity when determining treatment effectiveness, according to the poster. In fact, “the QOL measures in our study yielded information relatively independent of symptom measures,” said Mathew. Data were pulled from 2 randomised trials comparing 2 fixed-dose treatments of aripiprazole (10 and 30 mg) and placebo: a 6-week trial of 302 adolescents (aged 13-17 years, 57% male, 60% white) with schizophrenia and a 4-week trial of 296 patients (aged 10-17 years, 54% male, 65% white) with bipolar I disorder. In this secondary analysis study, the investigators evaluated mean changes from baseline in total scores and individual items from the self-administered Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q). Results showed that total score differences were not statistically significant at endpoint between the groups treated with aripiprazole and the groups treated with placebo. However, several of the individual items of the PQ-LES-Q did show significance (all P <= .05). For the schizophrenia patients, those treated with the 10-mg dose of aripiprazole had significant improvements in observed cases (OC) for the following items: health, mood/feelings, and overall. The significantly improved items for the 30-mg dose were helping at home, getting along with family, and overall. The overall category was not included in the total score. In the last observation carry forward (LOCF) measurement, those treated with the 10-mg dose of aripiprazole had significant improvements on mood/feelings and overall, while the 30-mg group reached significance on helping at home and overall. The OC for the bipolar disorder patients reached significance for the 30-mg group in the categories of getting along with family, getting/buying things, paying attention, and feelings about self, while the LOCF showed significant improvements for the same dosing group on getting along with family and getting/buying things. When all of the aripiprazole patients were combined and compared with all of those treated with placebo, the LOCF showed that the PG-LES-Q overall score was statistically significant (P < .002) at endpoint, while the OC data showed that both the overall and total scores reached statistical significance (P < .002 and P = .017, respectively). “Aripiprazole showed trends toward [QOL] improvements in both patients with schizophrenia and with bipolar, with a dose effect observed in the bipolar population,” said Mathew. “In addition, more of the items from the questionnaire reached significance in the observed case analysis compared with the [LOCF]. This may point to more improvement in QOL for those remaining in treatment.” “When looking at these results, if these are the items that are important to your patients or need improvement, then this treatment might be a choice that you want to consider,” she added. “On the other hand, if a different item is very important to them and this isn’t helping them, then that’s something that needs to be known also.” “This is just 1 more tool that clinicians can use when weighing the benefits and risks of treatment options and to manage expectations,” concluded Mathew. Funding for this study was provided by Otsuka Pharmaceutical Co, Ltd. [Presentation title: Quality of Life Improvement in Adolescent Schizophrenia and Pediatric Bipolar Disorder Following Treatment With Aripiprazole. Abstract P-6.43]
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