A Randomized, Double-Blind, Placebo-Controlled Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients With Alzheimer's, Vascular, or Mixed Dementia

Mean change in Simpson−Angus Scale Total score from baseline during intramuscular treatment. The Simpson−Angus Scale is a 10-item scale rated from 1 (normal) to 5 (worst), with a negative change on the Total score (scale 10–50) indicating a reduction in extrapyramidal symptoms.

Efficacy outcomes during intramuscular treatment. (A) Mean change in Positive and Negative Syndrome Scale Excited Component (PEC) score from baseline, (B) mean Clinical Global Impression–Improvement (CGI-I) score, (C) mean change in Agitation–Calmness Evaluation Scale (ACES) score from baseline (last observation carried forward data set). The PEC score consists of 5 PANSS items (hostility, lack of cooperation, excitement, poor impulse control, tension), each rated on a scale of 1 (absent) to 7 (extreme). A negative change from baseline in the PEC score (scale 5–35) signifies improvement. The CGI-I score is measured on a scale from 1 (very much improved) to 7 (very much worse), where a lower score signifies greater improvement. The ACES score is assessed on a scale of 1 (marked agitation) to 9 (unarousable); a score of 4 indicates normal; a positive change from baseline signifies improvement.