Assess the effectiveness and safety of transitioning patients with acute schizophrenia from IM to oral aripiprazole.

360 agitated patients (18-69 years) with PANSS Excited Component (PEC) total scores 15-32 and ≥4 on at least 2 PEC items, were randomized to ≤3 IM injections of aripiprazole 10 mg or haloperidol 6.5 mg within 24 hours. Patients (n=304) were transitioned to oral formulations (aripiprazole 10-15 mg/d or haloperidol 7-10 mg/d) for 4 days. Patients were assessed using PEC, Clinical Global Impression-Improvement (CGI-I), and Clinical Global Impression-Severity of Illness (CGI-S) Scale scores, as well as the Agitation Calmness Evaluation Scale (ACES), and the Corrigan Agitated Behavior Scale (CABS). Mean changes from baseline (last value obtained during IM treatment) to endpoint (Day 5, LOCF) were analyzed using an ANCOVA model controlling for treatment, country, and baseline value.

PEC scores were reduced 24 hours after IM injection with either aripiprazole or haloperidol (mean change of -8.3 and -8.1, respectively). Improvements in all other scales were also observed 24 hours following IM injection of aripiprazole or haloperidol. Treatment with oral aripiprazole or haloperidol for 4 days further reduced mean PEC scores (-1.4 aripiprazole, -1.4 haloperidol). Reductions in other scales were also maintained for 4 days following the transition to oral therapies. Incidence of AEs, and changes in laboratory values and vital signs were similar for both phases.

The effectiveness of aripiprazole and haloperidol appears to be maintained in patients with schizophrenia following transition from IM to oral formulations.