Intramuscular Ziprasidone, 2 mg Versus 10 mg, in the Short-Term Management of Agitated Psychotic Patients
J Clin Psychiatry 2001;62(1):12-18
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: There is a clear need
for effective, well-tolerated intramuscular (i.m.) agents for the acute
control of agitated psychotic patients. Currently used agents, including
conventional antipsychotics and/or benzodiazepines, may be associated
with distressing side effects such as extrapyramidal side effects and
Objective: The objective of this study was to
evaluate the efficacy and tolerability of the rapid-acting i.m.
formulation of the novel antipsychotic ziprasidone in the
treatment of inpatients with psychosis and acute agitation
Method: In a 24-hour, double-blind, fixed-dose
clinical trial, patients were 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 Activity 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 agitation 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 patient who received the 10-mg dose experienced the
extrapyramidal side effect akathisia.
Conclusion: Ziprasidone i.m., 10 mg, is rapidly
effective and well tolerated in the short-term management of the
agitated psychotic patient. Comparison with a study of identical
design comparing 2-mg with 20-mg doses in patients with similar
levels of psychopathology suggests that efficacy with 10 mg or 20
mg of ziprasidone i.m. is significant and dose related.