Study shows intramuscular delivery of Abilify improves acute agitation.

2004 JUN 11 - (NewsRx.com & NewsRx.net) -- Patients with schizophrenia, schizoaffective and schizophreniform disorders who received treatment with intramuscular (IM) administration of aripiprazole (Abilify) showed significant improvement in acute agitation as early as 45 minutes after dosing, according to a study presented at the 157th Annual Meeting of the American Psychiatric Association.

The study showed that treatment with IM aripiprazole resulted in significant symptom improvement in these patients, and was generally well tolerated, without excessive sedation or pain at the injection site.

"Patients experiencing acute agitation in schizophrenia are the most highly distressed and potentially disruptive group of patients," said David Daniel, MD, clinical professor of psychiatry at George Washington University. "This study shows that IM aripiprazole may help physicians control acutely agitated patients' symptoms quickly, without excessive sedation."

In a 24-hour, inpatient, double-blind, placebo-controlled study, 357 patients with schizophrenia, schizoaffective and schizophreniform disorders with acute agitation were randomized to IM aripiprazole (1 mg, 5 mg, 10 mg or 15 mg), IM haloperidol (7.5 mg), or placebo. Patients were evaluated according to the Positive and Negative Syndrome Scale - Excited Components (PEC), Agitation-Calmness Evaluation Scale (ACES) and Corrigan Agitated Behavior Scale (CABS) at baseline and every 15 minutes for the first 2 hours after dosing and then at 4, 6, 12 and 24 hours after dosing.

Aripiprazole (Abilify) 10 mg administered IM demonstrated significant reductions in PEC vs. placebo at 45 minutes (-4.39 vs. -2.22, p0.007) and 60 minutes (-5.48 vs. -2.41, p0.001) after dosing. Efficacy was maintained for the duration of the 24-hour study with IM aripiprazole 5 mg, 10 mg and 15 mg. Patients receiving IM haloperidol experienced significant reductions in PEC after 105 minutes vs. placebo (p0.004).

In addition, aripiprazole-treated patients showed a significant improvement in agitation as measured by ACES. The most common adverse event reported in the aripiprazole-treated groups was headache (range 7% to 18% vs. placebo 2%). IM aripiprazole was associated with minimal pain at the injection site (1 mg, 1.8%; 5 mg, 1.6%; 10 mg, 1.8%; 15 mg, 5.7%). No patients receiving IM haloperidol and 3.3% of those receiving placebo reported pain at the injection site. Incidence of any extrapyramidal symptoms with haloperidol was 19.3%; incidence with aripiprazole (average across all doses) was 5.2%.

Abilify (aripiprazole) was approved by the U.S. Food and Drug Administration (FDA) in 2002 for the treatment of schizophrenia. The efficacy of Abilify in schizophrenia ...