Individual symptom analysis in pivotal aripiprazole schizophrenia trials

Objective: The objective of this analysis was to evaluate the efficacy of aripiprazole for amelioration of individual symptoms in patients with acute exacerbation of schizophrenia.

Methods: On the basis of pooled data from four 4–6 week acute schizophrenia registrational trials (aripiprazole doses: 5–30mg/d; n=647 aripiprazole, 370 placebo) we analyzed PANSS total, positive, negative, and general psychopathology scales, as well as all 30 individual PANSS items using analysis of covariance (ANCOVA, controlling for baseline score and trial, LOCF method).

Results: On the PANSS total (–13.5 v. –3.1; p<0.001), positive (–4.1 v. –1.0; p<0.001), negative (–3.1 v. –0.8; p<0.001), and general psychopathology (–6.2 v. –2.3, p<0.001) scales, aripiprazole demonstrated statistically significant decreases in comparison with placebo. Further, in 27 out of 30 symptoms aripiprazole-treated patients also showed significant decreases in the severity of these individual symptoms compared to placebo (p<0.05).

Conclusion: This analysis has shown aripiprazole to be significantly more effective than placebo in the improvement of the majority of positive, negative, and general psychopathology symptoms in patients with acute schizophrenia.