Intramuscular ziprasidone, 2 mg versus 10 mg, in the short-term managementof agitated psychotic patients

Background: There is a clear need for effective, well-tolerated intramuscul ar (i.m.) agents for the acute control of agitated psychotic patients. Curr ently used agents, including conventional antipsychotics and/or benzodiazep ines, may be associated with distressing side effects such as extrapyramida l side effects and excessive sedation. Objective: The objective of this study was to evaluate the efficacy and tol erability of the rapid-acting i.m, formulation of the novel antipsychotic z iprasidone in the treatment of inpatients with psychosis and acute agitatio n (DSM-IV diagnoses). Method: In a 24-hour, double-blind, fixed-dose clinical trial, patients wer e randomly assigned to receive up to 4 injections (every 2 hours p.r.n,) of 2 mg (N = 54) or 10 mg (N = 63) of ziprasidone i.m. The Behavioral Activit y Rating Scale measured behavioral symptoms at baseline and the response to treatment up to 4 hours after the first i.m. injection. Results: Ziprasidone i.m., 10 mg, rapidly reduced symptoms of acute agitati on and was significantly more effective (p < .01) than the 2-mg dose up to 4 hours after the first injection. Patients were calmed but not excessively sedated, and over half were classed as responders 2 hours after the 10-mg dose. No acute dystonia or behavioral disinhibition was reported. One patie nt who received the 10-mg dose experienced the extrapyramidal side effect a kathisia. Conclusion: Ziprasidone i.m., 10 mg, is rapidly effective and well tolerate d in the short-term management of the agitated psychotic patient. Compariso n with a study of identical design comparing 2-mg with 20-mg doses in patie nts with similar levels of psychopathology suggests that efficacy with 10 m g or 20 mg of ziprasidone i.m, is significant and dose related.