Intramuscular (IM) ziprasidone 20 mg is effective in reducing acute agitation associated with psychosis: a double-blind, randomized trial

Rationale: Intramuscular (IM) conventional antipsychotics and/or benzodiaze pines are effective in the short-term treatment of acutely agitated psychot ic patients but may be associated with adverse effects. A short-acting IM f ormulation of the novel antipsychotic, ziprasidone, which may offer advanta ges over conventional agents, has been developed. Objective: To compare zip rasidone IM 2 mg (n=38) and 20 mg (n=41) in the acute control and short-ter m management of agitated psychotic patients. Methods: A prospective, random ized, double-blind, 24-h study assessed efficacy using the Behavioral Activ ity Rating Scale (BARS) and the PANSS. The BARS is a validated rating scale for the assessment of treatment response in acute agitation associated wit h psychosis. Following the initial dose, three more doses could be given 4 h apart if needed during the 24-h period. Results: The mean BARS score had decreased 15 min after the first 20 mg IM dose and was statistically signif icantly lower than the 2 mg group at 30 min post-dose. The improvement with the 20 mg dose increased until 2 h, and was maintained until at least 4 h post-dose (P<0.001). Two hours after the first injection, almost all of the patients receiving ziprasidone 20 mg were BARS responders compared with ju st one-third of those receiving 2 mg ziprasidone (P<0.001). The calming eff ect of ziprasidone was also evident by the significant reduction in PANSS a gitation items (P<0.05) and CGI-severity at 4 h (P=0.008). Both ziprasidone doses were very well tolerated. Ziprasidone IM 20 mg was not associated wi th EPS, dystonia, akathisia, respiratory depression or with excessive sedat ion. Conclusions: Ziprasidone IM 20 mg substantially and significantly redu ced the symptoms of acute agitation in patients with psychotic disorders. Z iprasidone 20 mg IM was very well tolerated and produced no dystonia or aka thisia.