Intramuscular aripiprazole or haloperidol and transition to oral therapy in patients with agitation associated with schizophrenia: sub-analysis of a double-blind study.

ABSTRACTObjective: A sub-population analysis of 325 patients with agitation (Positive and Negative Syndrome Scale Excited Component [PEC] score ≥ 15 and ≤ 32; score of ≥ 4 on ≥ 2 items) associated with schizophrenia in a randomized, double-blind study investigating the efficacy and tolerability of intramuscular (IM) aripiprazole 9.75 mg, IM haloperidol 6.5 mg, or IM placebo and the transition to oral therapy.Research design and methods: Over 24 h, patients could receive up to three IM injections; the second and third administered ≥ 2 and ≥ 4 h, respectively, after the first, if deemed clinically necessary. Following IM treatment, oral aripiprazole or haloperidol was administered for 4 days. The primary efficacy measure was the mean change in PEC score from baseline at 2 h.Results: At 2 h, mean improvements in PEC scores with IM aripiprazole (–8.0) were significantly greater versus IM placebo (–5.7; p ≤ 0.01), and similar versus IM haloperidol (–8.3). Secondary efficacy measures also significantly improved...