This study evaluated the efficacy and tolerability of intramuscular (IM) ziprasidone and the transition to oral formulation in patients with acute schizophrenia and agitation, whose severity of symptoms required IM treatment

Patients (n=150) were switched from their current treatments to 8 weeks of open-label treatment with ziprasidone. Patients received up to 40 mg/die IM ziprasidone at Day 1 and were then switched to 80-160 mg/die oral ziprasidone as soon as clinical status permitted. The primary efficacy measure was the change from baseline in PANSS total score. The effect of ziprasidone IM on agitation was evaluated using the validated 7-item Behavioural Assessment Rating Scale (BARS) scale

In the intent-to-treat population, the reduction in total PANSS score at study end point versus baseline was statistically significant (n = 150; -37.24; baseline 126.71; P< .0001). Regarding agitation, 142/150 (95%) patients were responders (BARS score 3-4), with a median time to response of 0.50 hours. A total of 61.3% of patients completed the study, 25% experienced treatment-related adverse events, and 5% discontinued due to adverse events. The most frequently reported adverse events were insomnia (6%), somnolence (4%), hypotension (3%), and extrapyramidal disorders (2%). No significant change was observed in weight or any clinical laboratory parameter

IM-to-oral ziprasidone proved effective and well tolerated in the treatment of patients suffering from acute exacerbation of schizophrenia with agitation, offering the possibility of continued treatment from the acute agitated state through to maintenance treatment without having to switch chemical entity.